Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0356-2008

Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002

Stryker Medical / initiated 2007-11-02 / Terminated / root cause: manufacturing process

Stryker Medical Div. of Stryker Corporation began a recall of Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0356-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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
Root cause tag
manufacturing process
FDA root cause
Process control
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.
Quantity in commerce
329 units total for both models.
Distribution
Worldwide-USA and Canada
Product codes and lots
All units (Model Number 2130/Serial Numbers: T01145 thru T01156, T01335 thru T01348 and TO1160 thru T01168)