Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1230-2009

Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050

Stryker Medical / initiated 2009-02-27 / Terminated / root cause: design

Stryker Medical Div. of Stryker Corporation began a recall of Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050 on . The reason FDA records is "The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1230-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050.
Product code
FPO Stretcher, Wheeled
Reason for recall
The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.
Root cause tag
design
FDA root cause
Device Design
Action
Consignees were notified by an Urgent - Medical Device Correction letter dated 2/27/09, advised of the problem and instructed to locate stretchers and verify that there is no grinding noise when activating the fowler electrically. Consignees were also instructed to remove any stretchers with a fowler that was non-operational, or which makes a grinding sound, from service until the firm makes repairs and contact the firm. Stretchers will be corrected within the next four months by a Stryker field service representative. The enclosed post card should be returned to confirm receipt of the notification. The notice should be forwarded to any users that have borrowed or purchased the stretchers and the firm should be notified of their new location. Also, if any of the affected stretchers have been disposed of or are no longer in use, the firm needs to be provided with their serial numbers. Questions or concerns should be directed to Andrea Kuthe at 269-324-6581.
Quantity in commerce
38
Distribution
Worldwide Distribution
Product codes and lots
Serial numbers 94113214, 94113215, 94113216, 94113217, 94113218, 94113219, 94113220, 94113221, 94113222, 94113223, 94113224, 94113225, 94113226, 94113227, 94113228, 94113229, 94113230, 94113231, 94113232, 94113233, 94113234, 94083551, 94083552, 94083553, 94083554, 94083555, 94083556, 94083557 A, 94083558, 94113211, 9501031208, 9501031209, 9501031210, 9501031211, 9503032237, 9503032238, 9503032239, and 9503032240.