Recall Z-1480-2013 ยท OSI Bariatric Bed
Kreg Medical Inc.
E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
| Date | Jun 5, 2013 (initiated Aug 2, 2012) |
| Status | Terminated |
| Reason | An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position. |
| Root cause | Device Design |
| Action | Kreg Medical sent an Urgent Voluntary Medical Device Recall letter dated May 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Kreg Medical started replacing potentially defective beds with refurbished beds in August 2012. All of the potentiall defective beds were refurbished by November 20, 2012. Customers were requested to send back the Medical Device Recall Return Response to confirm receipt of the notification letter. For questions regarding this recall call 312-275-7070. |
| Quantity | 59 beds |
| Distribution | Nationwide Distribution including IL and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.