Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0007-2007

Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064

Stryker Corp. / initiated 2006-09-08 / Terminated

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064 on . The reason FDA records is "A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0007-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
Product
Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.
Product code
HAW Neurological Stereotaxic Instrument
Reason for recall
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
FDA root cause
Other
Action
A recall letter dated 9/8/06 was sent to each customer instructing them to remove the battery from their Dell laptop computer model D800, to check the batteries to determine whether they are affected by the recall, and to only use the computer on AC power until they have requested and received replacement batteries.
Quantity in commerce
218 units for Recalls Z-0005/0008-2007
Distribution
Worldwide- USA and countries of Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Mexico, New Zealand, South Korea, Switzerland and United Kingdom.
Product codes and lots
All units.