Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0357-2008

Stryker inTouch Zoom Critical Care bed, Model 2140, 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 Zoom Critical Care bed, Model 2140, 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-0357-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker inTouch Zoom Critical Care bed, Model 2140, 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 2140/Serial Numbers: T01121, T01205, T01350, T01213 thru T01214, T01224, T01014 thru T01036, T01143, T01227, T01211, T01379 thru T01383, T01202, T01053 thru T01099. T01100 thru T01144, T01159, T01179, T01182, T01378, T01186, T01201, T01212, T01057, T01060,T01079,T01200, T01183, T01189, T01223, T01209, T01218, T01172, T01188, T01058, T01171, T01173, T01195, T01203, T01206, T01210, T01216, T01217, T01228, T01176, T01185, TO1193, T01207, T01225, T01215, T01229, T01187, T01311 thru T01320, T01230, T01175, T01180, T01190, T01196, T01037 thru T01052, T01198, T01184, T01192, T01177, T01194, T01204, T01219, T01199, T01191, T01226, T01181, T01197, T01222, T01231 thru T01308,T01208, T01349, T01221, QT01001 thru QT01012, QT01169 and QT01170)