Table, Operating-Room, Ac-Powered
FDA product code FQO · Class I (low risk) · 21 CFR 878.4960 · General, Plastic Surgery
35510(k) clearances
0PMA approvals
70recalls
Manufacturers
- Alm Surgical Equipment, Inc. 4
- Moon Surgical 2
- STERIS Corporation 2
- Stierlen-Maquet AG 2
- Rhino Mfg. 2
- Berchtold Holding GmbH 2
- Midmark Corp. 2
- American Sterilizer Co. 2
- Andronic Devices, Ltd. 2
- Koken Mfg Company, Inc. 2
- Kansas Creative Devices, Inc. 1
- Voss Medical Products 1
- Stryker Medical 1
- Mdt Technology For Life 1
- Mdt Corp., Inc. 1
- Skytron, Div. The KMW Group, Inc 1
- Leonard Medical, Inc. 1
- Kreuzer Corp. 1
- Tenet Medical Engineering 1
- Surgi-Quip Inc.U 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240598 | Maestro System (REF100)FQO · Traditional | Moon Surgical | 06/03/2024SE |
| K221410 | Maestro PlatformFQO · Traditional | Moon Surgical | 12/02/2022SE |
| K090136 | Steris Cmax XLT Surgical TableFQO · Traditional | STERIS Corporation | 03/20/2009SE |
| K972810 | OPT80 the Transportable (OPT80)FQO · Traditional | O.P.T. USA, Inc. | 08/26/1997SE |
| K971988 | Allen, Ultra and Smart SocketsFQO · Traditional | Allen Medical Systems, Inc. | 07/11/1997SE |
| K971307 | Amsco Surgical TableFQO · Traditional | STERIS Corporation | 06/27/1997SE |
| K963506 | Tenet Radiolucent Hand TableFQO · Traditional | Tenet Medical Engineering | 01/09/1997SE |
| K961886 | Drager Gemina Wall-Mounted WorkplaceFQO · Traditional | Alm Surgical Equipment, Inc. | 07/30/1996SE |
| K961742 | Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemFQO · Traditional | Alm Surgical Equipment, Inc. | 07/26/1996SE |
| K955750 | TeletomFQO · Traditional | Berchtold Holding GmbH | 02/08/1996SE |
| K953980 | Kreuzer Ceiling Mounted Support Systems, KlinoportFQO · Traditional | Kreuzer Corp. | 11/16/1995SE |
| K951854 | Leonard Arm - Support Arm - Endoscopic AccessoryFQO · Traditional | Leonard Medical, Inc. | 06/21/1995SE |
| K950192 | Skytron Skyboom SeriesFQO · Traditional | Skytron, Div. the Kmw Group, Inc. | 04/03/1995SE |
| K926463 | Rittermodel 75 Evolution Univ Pow Exam Table/AccesFQO · Traditional | Midmark Corp. | 10/21/1994SE |
| K942486 | Image Full Power Examination/Minor Surgery TableFQO · Traditional | Mdt Corp., Inc. | 08/10/1994SE |
| K942043 | Drager Dve 8000/1/2 Series Syst W/Dve 4002 and 8032EFQO · Traditional | Alm Surgical Equipment, Inc. | 07/13/1994SE |
| K941150 | MDT Shampaine 5100B and 5100E Surgical TablesFQO · Traditional | Mdt Technology For Life | 06/10/1994SE |
| K940068 | Stryker Operating Room TableFQO · Traditional | Stryker Medical | 05/05/1994SE |
| K936308 | Endex Endoscopic Positioning SystemFQO · Traditional | Andronic Devices, Ltd. | 03/31/1994SE |
| K926525 | Betastar 1131.02 Mobile Operating TableFQO · Traditional | Stierlen-Maquet AG | 10/12/1993SE |
| K930493 | Quantum 3080 Surgical TableFQO · Traditional | American Sterilizer Co. | 06/22/1993SE |
| K932186 | Bypass Leg PositionerFQO · Traditional | Voss Medical Products | 06/01/1993SE |
| K924700 | Fisk HeadrestFQO · Traditional | Rhino Mfg. | 01/15/1993SE |
| K921297 | Drager Dve 4000 Series SystemFQO · Traditional | Alm Surgical Equipment, Inc. | 11/27/1992SE |
| K921143 | Pneumo-WedgeFQO · Traditional | Kansas Creative Devices, Inc. | 09/11/1992SE |
| K920890 | Operating Table System-Betamaquet 1140FQO · Traditional | Stierlen-Maquet AG | 07/02/1992SE |
| K922371 | Spinal Positioning FrameFQO · Traditional | Rhino Mfg. | 06/04/1992SE |
| K921626 | Teletom(R)FQO · Traditional | Berchtold Holding GmbH | 05/05/1992SE |
| K915141 | 712 Plastic Surgery Table & AccesoriesFQO · Traditional | Midmark Corp. | 01/09/1992SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | American Sterilizer Co. | 07/25/1988SE |
| K880227 | Arthrobot(Tm) Lower Limb PositionerFQO · Traditional | Andronic Devices, Ltd. | 02/18/1988SE |
| K864325 | DR7700 Operating TableFQO · Traditional | Koken Mfg Company, Inc. | 11/19/1986SE |
| K864295 | DR.500O Operating TableFQO · Traditional | Koken Mfg Company, Inc. | 11/19/1986SE |
| K841115 | Charles/Mcintyre Giant Break TableFQO · Traditional | Surgi-Quip Inc.U | 05/09/1984SE |
| K831086 | Ceiling Mounted SupportFQO · Traditional | Amsco Co. | 08/12/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3033-2026 Class II | ORT200, operating room table, including the ORT200 Covered Table Assembly…The linear actuator and rotational lock mechanism components may experience a mechanical failure that… | IMRIS Imaging Inc | 08/06/2026Open, Classified |
| Z-2420-2025 Class II | Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4)…Under certain conditions, such as the simultaneous use of the operating table with other medical devices… | Maquet GmbH | 07/14/2025Open, Classified |
| Z-1663-2025 Class II | Skytron Freedom 4FXS-60 Heavy Duty Monitor MountThe mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread… | Ihb Operations B.V. | 03/27/2025Open, Classified |
| Z-0463-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-0462-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-0461-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-0460-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-0459-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-0458-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-0457-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-0456-2025 Class II | MEERA CL mobile operating table - Designed for the placement and positioning of the…Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the… | Getinge Usa Sales Inc | 10/03/2024Open, Classified |
| Z-2273-2024 Class II | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and… | Getinge Usa Sales Inc | 05/29/2024Open, Classified |
| Z-2272-2024 Class II | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and… | Getinge Usa Sales Inc | 05/29/2024Open, Classified |
| Z-2271-2024 Class II | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and… | Getinge Usa Sales Inc | 05/29/2024Open, Classified |
| Z-0036-2024 Class II | Meera Mobile Operating Table-to support and position the patient immediately before…Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence… | Getinge Usa Sales Inc | 09/06/2023Open, Classified |
| Z-0452-2024 Class II | Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with…Weakened connection point on the adjustable suspension arm, potentially causing damage or a break. | Ihb Operations B.V. | 07/19/2023Open, Classified |
| Z-0239-2023 Class II | Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20ANThe back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were… | Getinge Usa Sales Inc | 10/14/2022Open, Classified |
| Z-1309-2022 Class II | Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-AUnder certain circumstances, the mounting screws may loosen or pull out from the attachment point on the… | Skytron, Div. The KMW Group, Inc | 06/02/2022Open, Classified |
| Z-1861-2021 Class II | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket…Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and… | Skytron, Div. The KMW Group, Inc | 05/11/2021Open, Classified |
| Z-1296-2021 Class II | Operating Table SystemThere is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended… | Getinge Group Logistics America, LLC | 02/11/2021Open, Classified |
| Z-1297-2021 Class II | S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502…The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System… | Stryker Communications | 01/29/2021Open, Classified |
| Z-0133-2021 Class II | Yuno II Mobile Operating Table - Product Usage: support and position the patient…Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where… | Maquet Cardiovascular Us Sales, Llc | 09/24/2020Terminated |
| Z-0132-2021 Class II | Yuno Mobile Operating Table - Product Usage: Intended for support and position the…Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where… | Maquet Cardiovascular Us Sales, Llc | 09/24/2020Terminated |
| Z-1569-2020 Class II | Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount…Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the… | Skytron, Div. The KMW Group, Inc | 03/05/2020Open, Classified |
| Z-0648-2019 Class II | IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b)…Table may drift in the roll position while in use | Deerfield Imaging, Inc. | 11/06/2018Terminated |
| Z-0647-2019 Class II | IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b)…Table may drift in the roll position while in use | Deerfield Imaging, Inc. | 11/06/2018Terminated |
| Z-0646-2019 Class II | IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The…Table may drift in the roll position while in use | Deerfield Imaging, Inc. | 11/06/2018Terminated |
| Z-0645-2019 Class II | IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d)…Table may drift in the roll position while in use | Deerfield Imaging, Inc. | 11/06/2018Terminated |
| Z-1266-2018 Class II | IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600The Operating Room Table may drift while in use, which could potentially result in unintended movement of… | Deerfield Imaging, Inc. | 02/23/2018Terminated |
| Z-1265-2018 Class II | IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600The Operating Room Table may drift while in use, which could potentially result in unintended movement of… | Deerfield Imaging, Inc. | 02/23/2018Terminated |
| Z-1264-2018 Class II | IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b)…The Operating Room Table may drift while in use, which could potentially result in unintended movement of… | Deerfield Imaging, Inc. | 02/23/2018Terminated |
| Z-1263-2018 Class II | IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600The Operating Room Table may drift while in use, which could potentially result in unintended movement of… | Deerfield Imaging, Inc. | 02/23/2018Terminated |
| Z-1218-2018 Class II | IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during…The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change… | Deerfield Imaging, Inc. | 02/23/2018Terminated |
| Z-1217-2018 Class II | IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during…The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change… | Deerfield Imaging, Inc. | 02/23/2018Terminated |
| Z-0976-2018 Class II | IMRIS T2X Table, Part Number 109682-600The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use… | Deerfield Imaging, Inc. | 02/20/2018Terminated |
| Z-0390-2017 Class II | Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of…Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a… | Maquet Medical Systems USA | 10/05/2016Terminated |
| Z-2746-2016 Class II | The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element…Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the… | Maquet Cardiovascular Us Sales, Llc | 08/12/2016Terminated |
| Z-1871-2016 Class II | Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single…Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the… | Skytron, Div. The KMW Group, Inc | 03/28/2016Terminated |
| Z-1045-2016 Class II | Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to…MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part… | Maquet Cardiovascular Us Sales, Llc | 01/07/2016Terminated |
| Z-0655-2016 Class II | Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display…The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing… | Skytron, Div. The KMW Group, Inc | 12/02/2015Terminated |
| Z-0154-2016 Class II | TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in…During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work… | Berchtold Corp. | 09/23/2015Terminated |
| Z-2097-2015 Class II | Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego…There is a potential issue that could result to collision between the C-arm of the angiography system and… | Maquet Cardiovascular Us Sales, Llc | 06/10/2015Terminated |
| Z-0144-2015 Class II | IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic…One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR… | IMRIS Inc | 10/01/2014Terminated |
| Z-2026-2014 Class II | The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically…STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not… | Steris Corporation | 06/27/2014Terminated |
| Z-0282-2014 Class II | Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating…Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in… | Draeger Medical, Inc. | 09/30/2013Terminated |
| Z-2108-2012 Class II | Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version…As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a… | Maquet Medical Systems, Usa | 04/13/2012Terminated |
| Z-0279-2012 | STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT-…Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by… | Steris Corporation | 10/17/2011Terminated |
| Z-0519-2012 | Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and…SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is… | Smith & Nephew, Inc. Endoscopy Division | 07/26/2011Terminated |
| Z-0398-2012 | OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories.Product is being recalled due to unintended movement on the Titan Tables. | Trumpf Medical Systems, Inc. | 01/21/2011Terminated |
| Z-0397-2012 | OR table TITAN U, Surgical Table. Surgical bed with Orthopedic Accessories.Product is being recalled due to unintended movement on the Titan Tables. | Trumpf Medical Systems, Inc. | 01/21/2011Terminated |