Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002
FDA Recall Z-0356-2008 · Posted 2007-12-08
Recalling FirmStryker Medical Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2007-11-02
Date Terminated2010-10-27
Product Quantity329 units total for both models.
Reason for Recall
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
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide-USA and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.