Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1687-2008

Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115 V, Stryker Medical, Portage, MI.; Model...

Stryker Medical / initiated 2008-02-01 / Terminated / root cause: design

Stryker Medical Div. of Stryker Corporation began a recall of Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115 V, Stryker Medical, Portage, MI.; Model 2040 on . The reason FDA records is "The brakes may not have adequate holding power to lock the bed in place". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1687-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115 V, Stryker Medical, Portage, MI.; Model 2040.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
The brakes may not have adequate holding power to lock the bed in place.
Root cause tag
design
FDA root cause
Device Design
Action
Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
Quantity in commerce
66,558 of all models.
Distribution
Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.
Product codes and lots
Serial numbers 0409060516 through 0711096116.