Recall Z-1689-2008 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Div. of Stryker Corporation
Stryker Medical Epic II Critical Care Bed, 230 V, Stryker Medical, Portage, MI.; Model 2031 (not sold in the U.S.).
| Date | Sep 19, 2008 (initiated Feb 1, 2008) |
| Status | Terminated |
| Reason | The brakes may not have adequate holding power to lock the bed in place. |
| Root cause | Device Design |
| Action | Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem. |
| Quantity | 66,558 of all models. |
| Distribution | Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.