Recall Z-2214-2009 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Div. of Stryker Corporation
Stryker Epic II critical care bed, 230v, Stryker Medical, Portage, MI; Model 2031. (Note: This product is not sold in the US). Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.
| Date | Sep 18, 2009 (initiated Aug 10, 2009) |
| Status | Terminated |
| Reason | The backrest of the bed may not stay in an upright position (may drift down when left raised). |
| Root cause | Device Design |
| Action | Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections short |
| Quantity | 12,599 of all products |
| Distribution | Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.