Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. Th

FDA device recall Z-0943-2009 · posted 2009-02-25 · Terminated

Recall details

Recalling firm

Stryker Medical Div. of Stryker Corporation

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

Action taken

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

Status

Terminated

Product code

FNL

Quantity affected

1,288 of all models

Distribution

Worldwide Distribution including USA and countries of Canada, Japan and Switzerland.

Date initiated

2009-01-05

Date posted

2009-02-25

Date terminated

2010-11-05

Location

Portage, MI