Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2213-2009

Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model 2030. Beds are A/C powered...

Stryker Medical / initiated 2009-08-10 / Terminated / root cause: design

Stryker Medical Div. of Stryker Corporation began a recall of Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model 2030. Beds are A/C powered hospital beds that are intended for medical purposes... on . The reason FDA records is "The backrest of the bed may not stay in an upright position (may drift down when left raised)". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2213-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model 2030. Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
The backrest of the bed may not stay in an upright position (may drift down when left raised).
Root cause tag
design
FDA root cause
Device Design
Action
Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly. For further information, contact Stryker Medical at 1-269-324-6527.
Quantity in commerce
12,599 total products
Distribution
Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.
Product codes and lots
Note these serial numbers are inclusive for models 2030 and 2031. Serial Numbers: 0801098563, 0801098564, 0801098565, 0801098566, 0801098567, 0801098568, 0801098730, 0801098733, 0801098734, 0801098783, 0801098784, 0801098785, 0801098786, 0801098787, 0801098788, 0801098789, 0801098790, 0801098791, 0801098792, 0801098793, 0801098794, 0802102180, 0802102200, 0802102215, 0802102216, 0802102217, 0802102218, 0802102219, 0802102220, 0802102221, 0802102222, 0802102223, 0802102224, 0802102225, 0802102226, 0802102232, 0802102233, 0802102234, 0802102235, 0802102236, 0802102237, 0802102238, 0802102239, 0802102240, 0802102258, 0802102259, 0802102260, 0802102261, 0802102262, 0802102263, 0802102264, 0802102265, 0802102266, 0802102267, 0802102268, 0802102269, 0802102270, 0802102271, 0802102272, 0802102281, 0802102282, 0802102283, 0803101559, 0803101560, 0803101561, 0803101562, 0803101563, 0803101564, 0803101586, 0803101587, 0803101588, 0803101589, 0803101590, 0803101591, 0803101592, 0803101593, 0803101612, 0803101613, 0803101614, 0803101615, 0803101616, 0803101617, 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