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

FDA device recall Z-0357-2008 · posted 2007-12-08 · Terminated

Recall details

Recalling firm

Stryker Medical Div. of Stryker Corporation

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

Action taken

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

Status

Terminated

Product code

FNL

Quantity affected

329 units total for both models.

Distribution

Worldwide-USA and Canada

Date initiated

2007-11-02

Date posted

2007-12-08

Date terminated

2010-10-27

Location

Portage, MI