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.
FDA Recall Z-0942-2009 · Posted 2009-02-25
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Recalling FirmStryker Medical Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2009-01-05
Date Terminated2010-11-05
Product Quantity1,288 of all models
Reason for Recall
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution including USA and countries of Canada, Japan and Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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