Recall Z-0357-2008 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Div. of Stryker Corporation
Stryker inTouch Zoom Critical Care bed, Model 2140, Stryker Medical, Portage, MI 49002
| Date | Dec 8, 2007 (initiated Nov 2, 2007) |
| Status | Terminated |
| Reason | Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re |
| Root cause | Process control |
| Action | Consignees were notified via an Urgent Medical Device Correction letter dated 11/2/07, and instructed to remove the beds from service if they display any unintended motions and informed that one of the firm's field service representatives will visit the facility to make corrections to all beds under recall. |
| Quantity | 329 units total for both models. |
| Distribution | Worldwide-USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.