Arjo, Inc.
Medical device manufacturer in Roselle, IL.
1510(k) clearances
0PMA approvals
28recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K001079 | Recumbent Bathing Systems, Rhapsody and PrimoILJ · Traditional | 05/01/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0933-2009 | Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC…The manufacturer, BHM Medical, has received reports of structural failure of the mast during use. | 12/08/2008Terminated |
| Z-0503-2009 | Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC…The battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift or as replacement parts, has… | 11/05/2008Terminated |
| Z-0413-2009 | Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic Positioning System) and…If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself… | 10/30/2008Terminated |
| Z-0412-2009 | Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient…If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself… | 10/30/2008Terminated |
| Z-0323-2009 | Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a…The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the… | 10/20/2008Terminated |
| Z-0322-2009 | Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient…The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the… | 10/20/2008Terminated |
| Z-2470-2008 | Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo…There is the potential for unintended dislocation of the Lock and Load hanger assembly (Combi Hanger) from… | 09/08/2008Terminated |
| Z-2434-2008 | Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift…There is a possibility that the Kwiktrak Gate System could malfunction, resulting in the gate locks opening… | 08/01/2008Terminated |
| Z-1651-2008 | Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift…The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The… | 05/05/2008Terminated |
| Z-1650-2008 | Ambulift, standard basic model manually powered patient lift. The Ambulift is used to…The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The… | 05/05/2008Terminated |
| Z-1557-2008 | Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000…Scale could break and fall potentially causing injuries to someone who is on it. There is a potential for… | 04/10/2008Terminated |
| Z-1233-2008 | BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of…The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a… | 02/20/2008Terminated |
| Z-1136-2008 | BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by…Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar… | 12/19/2007Terminated |
| Z-1135-2008 | BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by…Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar… | 12/19/2007Terminated |
| Z-0261-2008 | ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient…Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care… | 10/15/2007Terminated |
| Z-1234-2008 | Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061…Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the… | 01/23/2007Terminated |
| Z-0426-2007 | Sara Active Sling - Standard; item KK53210.0 - model KA1210 (with safety); manufactured…There is the potential for the slings to come apart, potentially allowing injury to the patient. | 01/09/2007Terminated |
| Z-0425-2007 | Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241…There is the potential for the slings to come apart, potentially allowing injury to the patient. | 01/09/2007Terminated |
| Z-0424-2007 | Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240…There is the potential for the slings to come apart, potentially allowing injury to the patient. | 01/09/2007Terminated |
| Z-0799-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov…The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting… | 01/05/2007Terminated |
| Z-0798-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov…The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting… | 01/05/2007Terminated |
| Z-0797-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov…The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting… | 01/05/2007Terminated |
| Z-0796-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov…The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting… | 01/05/2007Terminated |
| Z-0482-2007 | BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to…The carabineer may not be correctly attached to the reacher and the portable patient lift may drop. | 11/13/2006Terminated |
| Z-0249-2007 | Sling Rope/Connector Assembly Kits for the Sara Power standing and raising aids; the kit…The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from… | 10/30/2006Terminated |
| Z-0248-2007 | Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids…The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from… | 10/30/2006Terminated |
| Z-0479-2007 | BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600…The Kwiktrak Gate stopper may fail and allow the ceiling lift to pass through to the end of the track and… | 10/23/2006Terminated |
| Z-0478-2007 | Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc.…The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt. | 08/31/2006Terminated |