Hill-Rom, Inc.
Medical device manufacturer in Batesville, IN.
37510(k) clearances
0PMA approvals
76recalls
Device types
- IOQ Bed, Flotation Therapy, Powered 7
- FNL Bed, Ac-Powered Adjustable Hospital 5
- FMT Warmer, Infant Radiant 4
- FPO Stretcher, Wheeled 4
- IKZ Bed, Patient Rotation, Powered 2
- BZQ Monitor, Breathing Frequency 2
- KNC Table, Obstetric (And Accessories) 2
- KDP Regulator, Vacuum 1
- FOX Stand, Infusion 1
- IQA System, Environmental Control, Powered 1
- IPT Orthosis, Thoracic 1
- INX Bed, Air Fluidized 1
- FSY Light, Surgical, Ceiling Mounted 1
- DWJ System, Thermal Regulating 1
- FET Endoscopic Video Imaging System/Component… 1
- INK Stretcher, Wheeled, Powered 1
- HDD Table, Obstetrical, Ac-Powered (And… 1
- MSX System, Network And Communication… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260211 | Dashboard (P007000)MSX · Traditional | 08/13/2026SE |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…BZQ · Traditional | 03/04/2021SE |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…BZQ · Traditional | 05/07/2018SE |
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | 06/03/2013SE |
| K112502 | Procedural Strecher with Intellidrive P8000INK · Traditional | 09/19/2011SE |
| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | 11/16/2001SE |
| K973705 | Contor Table SurfaceDWJ · Traditional | 08/07/1998SE |
| K981081 | BrightstarFSY · Traditional | 04/29/1998SE |
| K972111 | Rumors Dynamic Air Therapy UnitIKZ · Traditional | 02/02/1998SE |
| K971366 | IncuwarmerFMT · Traditional | 01/05/1998SE |
| K970636 | Totalcare., Modular Therapy System (MTS)IOQ · Traditional | 08/26/1997SE |
| K964873 | Silkair Low Airloss TherapyIOQ · Traditional | 07/03/1997SE |
| K964223 | Clinitron Rite-HiteINX · Traditional | 05/28/1997SE |
| K970295 | Flexicair Exlipse PlusIOQ · Traditional | 05/16/1997SE |
| K970074 | Stanilet Freestanding/Cc INFANT/2000C Infant Warmer (1250C/1500C/2000D)FMT · Traditional | 04/03/1997SE |
| K962942 | TotalcareFNL · Traditional | 02/03/1997SE |
| K963091 | Vollman Prone PositionerIPT · Traditional | 01/09/1997SE |
| K961437 | Wheeled StretcherFPO · Traditional | 06/03/1996SE |
| K952447 | Hill-Rom Ambulatory Care Procedural StretcherFPO · Traditional | 11/22/1995SE |
| K951001 | Flexicair ExlipseIOQ · Traditional | 06/27/1995SE |
| K950756 | Pulmonex Dynamic Air Therapy UnitIKZ · Traditional | 05/30/1995SE |
| K944580 | Flexsys Mobilemate Equipment StandFOX · Traditional | 03/17/1995SE |
| K945729 | Dynamicaire(Tm) Sleep Surface, Zoneair(Tm) Sleep SurfaceIOQ · Traditional | 02/27/1995SE |
| K942904 | StabiletFMT · Traditional | 09/16/1994SE |
| K924420 | Medical Disposable BeddingKNC · Traditional | 12/10/1993SE |
| K926140 | Vacuum Power Body Fluid Suction ApparatusKDP · Traditional | 07/27/1993SE |
| K922809 | General Procedural Stretchers (P880- P886)FPO · Traditional | 03/31/1993SE |
| K922808 | Hill-Rom Via Stretcher (P1300 - P1303)FPO · Traditional | 03/31/1993SE |
| K915779 | Affinity Bed Model 3600 SeriesKNC · Traditional | 02/24/1993SE |
| K922352 | The Advance Series From Hill-RomFNL · Traditional | 10/13/1992SE |
| K915437 | Critical Care Hospital Bed (Icu/Ccu)FNL · Traditional | 06/11/1992SE |
| K921528 | Hill-Rom Patient Environmental Control SystemIQA · Traditional | 04/20/1992SE |
| K914309 | The Genesis Bed From Hill-Rom, Model 355 SeriesHDD · Traditional | 04/20/1992SE |
| K913945 | Stabilet Infant Radiant Warmer Model 2000CFMT · Traditional | 02/12/1992SE |
| K864186 | Hill-Rom Century CC Models 892 &894 (Radiolucent)FNL · Traditional | 11/13/1986SE |
| K864172 | Hill-Rom Century CC, Models 891 & 893 Weighing SysFNL · Traditional | 11/13/1986SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0783-2022 Class II | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift…Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate… | 01/14/2022Terminated |
| Z-0640-2022 Class II | Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | 12/23/2021Open, Classified |
| Z-0639-2022 Class II | Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | 12/23/2021Open, Classified |
| Z-0402-2022 Class II | These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6…An unrecoverable error may occur where a component will fail to complete the reboot cycle, become… | 10/14/2021Terminated |
| Z-2601-2021 Class II | LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number:…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | 08/11/2021Open, Classified |
| Z-2600-2021 Class II | LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | 08/11/2021Open, Classified |
| Z-2599-2021 Class II | Stretch Leveller Model Number: 3156200 - The combination of this products allows the…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | 08/11/2021Open, Classified |
| Z-2598-2021 Class II | FlexoStretch Model Number: 3156057 - The combination of this products allows the user to…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | 08/11/2021Open, Classified |
| Z-2597-2021 Class II | OctoStretch with Stretch Leveller - The combination of this products allows the user to…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | 08/11/2021Open, Classified |
| Z-2156-2021 Class II | Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an…Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could… | 05/28/2021Terminated |
| Z-0925-2021 Class I | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the…Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the… | 12/18/2020Terminated |
| Z-2738-2020 Class II | Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or…Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of… | 06/30/2020Terminated |
| Z-2737-2020 Class II | Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or…Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of… | 06/30/2020Terminated |
| Z-2246-2020 Class II | Centrella Smart+ Bed, Catalog Number P7900The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was… | 04/30/2020Terminated |
| Z-1554-2020 Class II | NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety…There is a software issue which may result in failure to monitor or control patient's bed exit mechanism. | 02/14/2020Terminated |
| Z-1319-2018 Class II | Progressa Bed - AC-powered adjustable hospital bedA component used within the braking system may break resulting in one or more brake pedals on the bed… | 01/12/2018Terminated |
| Z-1816-2017 Class II | TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient…The bed exit alarm may not function properly if the alarm has been armed for a period longer than… | 02/23/2017Terminated |
| Z-0326-2017 Class II | Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail…Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if… | 08/09/2016Terminated |
| Z-2750-2016 Class II | Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and… | 07/15/2016Terminated |
| Z-2376-2016 Class II | Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered…The current construction of the side rail latch may not be able to support the full patient weight and may… | 06/14/2016Terminated |
| Z-1916-2016 Class II | Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal…The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the… | 03/08/2016Terminated |
| Z-0860-2016 Class II | Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered…The recliners were shipped without the foot rest ottoman linkage side shields, which could result in… | 01/20/2016Terminated |
| Z-0274-2016 Class II | Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bedHill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting… | 10/07/2015Terminated |
| Z-1818-2015 Class II | Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm… | 03/20/2015Terminated |
| Z-1820-2015 Class II | Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. | 03/02/2015Terminated |
| Z-2562-2014 Class II | Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing…The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could… | 06/26/2014Terminated |
| Z-1794-2013 Class II | TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress…When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of… | 05/30/2013Terminated |
| Z-1476-2013 Class II | SlingBar Standard. Designed to meet the needs for lifting humans.Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver… | 04/30/2013Terminated |
| Z-1475-2013 Class II | SlingBar Wide 670. Designed to meet the needs for lifting humans.Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver… | 04/30/2013Terminated |
| Z-1474-2013 Class II | SlingBar 360. Designed to meet the needs for lifting humans.Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver… | 04/30/2013Terminated |
| Z-1473-2013 Class II | SlingBar 350. Designed to meet the needs for lifting humans.Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver… | 04/30/2013Terminated |
| Z-1466-2013 Class II | Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to…Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to… | 04/15/2013Terminated |
| Z-0949-2013 Class II | TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in…In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to… | 02/26/2013Terminated |
| Z-0622-2013 Class II | Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can…Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received… | 12/06/2012Terminated |
| Z-0872-2013 Class II | Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts…Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has… | 10/31/2012Terminated |
| Z-1864-2012 Class II | Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the…During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used… | 06/18/2012Terminated |
| Z-2082-2012 Class II | Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is…During review of our last braking system via that field corrective action, the system still did not meet our… | 04/02/2012Terminated |
| Z-1132-2012 | Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air…The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards… | 02/03/2012Terminated |
| Z-1131-2012 | Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized…The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards… | 02/03/2012Terminated |
| Z-1565-2011 | VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom…Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the… | 02/21/2011Terminated |
| Z-1564-2011 | VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom…Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the… | 02/21/2011Terminated |
| Z-1563-2011 | TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN.…Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the… | 02/21/2011Terminated |
| Z-1396-2011 | Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko…Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were… | 02/09/2011Terminated |
| Z-1221-2011 | Hill-Rom TotalCare Bariatric Bed, P1840, Hill-Rom, Batesville, IN. TheTotalCare Bed…The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually… | 02/03/2011Terminated |
| Z-1220-2011 | Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is…The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually… | 02/03/2011Terminated |
| Z-1697-2011 | Liko Capella 201 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1696-2011 | Liko Sabina 200 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1695-2011 | Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1694-2011 | Liko Sabina II EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1693-2011 | Liko Sabina EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1692-2011 | Liko Sabina II EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1691-2011 | Liko Sabina EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-2094-2010 | Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000…The firm received a complaint regarding the plastic housing used to support the trapeze handle. The firm… | 06/11/2010Terminated |
| Z-0333-2011 | Excel Care ES Bariatric Bed, P 610B, Hill-Rom, Batesville, IN. Intended use: The Excel…The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The… | 03/05/2010Terminated |
| Z-0332-2011 | Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN. Intended Use: The Excel Care…The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The… | 03/05/2010Terminated |
| Z-1065-2010 | Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840. The…The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to… | 01/01/2010Terminated |
| Z-0548-2010 | Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model…The brakes may not hold or lock. | 11/16/2009Terminated |
| Z-2170-2010 | Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | 09/16/2009Terminated |
| Z-2169-2010 | Hill-Rom Basic Care Bed, P1440A (Electric), Hill Rom Batesville, IN. Intended for low to…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | 09/16/2009Terminated |
| Z-2168-2010 | Hill-Rom 405 Bed, P1440B, (electric) Hill Rom Batesville, IN. Intended for low to…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | 09/16/2009Terminated |
| Z-2167-2010 | Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | 09/16/2009Terminated |
| Z-0338-2010 | Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.The siderails may exhibit false latching, or unintentional lowering, or may become inoperable. | 04/20/2009Terminated |
| Z-2268-2010 | Hill-Rom 1000 bed model P1160.Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the… | 04/13/2009Terminated |
| Z-2267-2010 | Hill-Rom Care Assist Bed, Model P1170.Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the… | 04/13/2009Terminated |
| Z-1317-2009 | Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide…An e-ring may not have been installed during production, which could result in an inability to latch the… | 03/09/2009Terminated |
| Z-0506-2009 | Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed…Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest… | 11/11/2008Terminated |
| Z-1777-2008 | Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers…A risk of entrapment will exist between the head and foot rails if installation instructions are followed. | 04/28/2008Terminated |
| Z-1603-2008 | Hill-Rom 100 Low Bed; Model No. P3930.The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved… | 04/08/2008Terminated |
| Z-1655-2008 | Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital…The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is… | 04/03/2008Terminated |
| Z-0584-2008 | Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | 11/21/2007Terminated |
| Z-0583-2008 | Hill-Rom Affinity Three Birthing Bed, Model P3700A.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | 11/21/2007Terminated |
| Z-0582-2008 | Hill-Rom Affinity Two Birthing Bed, Model P3600.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | 11/21/2007Terminated |
| Z-0581-2008 | Hill-Rom Affinity Birthing Bed, Model P3600.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | 11/21/2007Terminated |
| Z-0617-2008 | Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006Brake failure: The brakes may not hold or lock properly. | 09/06/2007Terminated |
| Z-0240-2008 | Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN…False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in… | 11/12/2006Terminated |
| Z-0017-2007 | Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02…The patient pendant cord represents a potential trip hazard for the patient or the caregiver. | 07/27/2006Terminated |