Recall Z-2586-2010 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Div. of Stryker Corporation
Stryker Epic II Critical Care Bed, Model 2030/2031, Stryker Medical, Kalamazoo, MI. Critical Care Patient Bed.
| Date | Sep 28, 2010 (initiated May 14, 2010) |
| Status | Terminated |
| Reason | The Fowler mechanism may malfunction, preventing it from being lowered into a flat position. |
| Root cause | Component change control |
| Action | Stryker Medical sent an Urgent Medical Device Alert letter dated May 14, 2010 to their customers. The letter identified the product, the problem, and the actions customers should take. The letter instructed users to do the following: " Return the postcard included with the letter to confirm receipt of the notification. " Locate the recalled beds, verify the Fowler mechanism is functioning properly and does not display uneven motion when raising and lowering, and is not unusually noisy. " If the Fowler mechanism is not operating correctly, they were to call Stryker at 1 |
| Quantity | 9,134 |
| Distribution | Worldwide Distribution - USA (all states), and including the countries of ARGENTINA, BRAZIL, CHILE, CHINA, CANADA, MEXICO, GREECE, JAPAN, KOREA, PUERTO RICO, SPAIN, POLAND, TAIWAN, SINGAPORE, INDIA, SWITZERLAND, UK and MALAYSIA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.