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Terminated

Stryker inTouch Zoom Critical Care bed, Model 2140, Stryker Medical, Portage, MI 49002

FDA Recall Z-0357-2008 · 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.

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