Recall Z-1946-2009 ยท FSA Lift, Patient, Non-Ac-Powered
ArjoHuntleigh
ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden. The equipment is intended for hygiene care, showering, and toileting of hospital or nursing home residents under the supervision of trained nursing staff and in accordance with the instructions outlined in the Operating and Product Care Instructions
| Date | Sep 8, 2009 (initiated Jun 11, 2009) |
| Status | Terminated |
| Reason | Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position. |
| Root cause | Device Design |
| Action | ArjoHuntleigh sent Urgent Device Field Correction letters dated June 11, 2009, along with the Urgent Field Safety Notice ID 090526AHE dated May 26, 2009, via UPS Ground delivery. Customers were informed of the affected device and were requested to complete the response form with new contact information and fax it back to ArjoHuntleigh at 630-567-5012 or 630-925-7969. For further questions, contact ArjoHuntleigh at 1-800-323-1245. |
| Quantity | 1,987 hygiene chairs |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.