Recall Z-0942-2009 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Div. of Stryker Corporation
Stryker InTouch 1.0 Critical Care Bed (Model 2130) with the Integrated PositionPro mattress (Model 2920) option. 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. Also, the "hold" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to ho |
| 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.