Recall Z-0940-2009 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Div. of Stryker Corporation
Stryker InTouch 1.0 Critical Care Bed; Model 2130. The device is intended to be used as an Intensive Care Unit bed.
| Date | Feb 25, 2009 (initiated Jan 5, 2009) |
| Status | Terminated |
| Reason | The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. |
| Root cause | Device Design |
| Action | Consignees were notified of the problems via letter dated January 5, 2009, advised to check their beds and to take them out of service if the foot board touchscreen displayed a "tilt over range" error, and that a Stryker Medical field service representative would contact them to perform software upgrades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644. |
| Quantity | 1,288 of all models |
| Distribution | Worldwide Distribution including USA and countries of Canada, Japan and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.