ClearanceBrief
Recall Z-0007-2007 ยท HAW Neurological Stereotaxic Instrument

Stryker Instruments Div. of Stryker Corporation

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

DateOct 3, 2006 (initiated Sep 8, 2006)
StatusTerminated
ReasonA component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
Root causeOther
ActionA 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.
Quantity218 units for Recalls Z-0005/0008-2007
DistributionWorldwide- USA and countries of Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Mexico, New Zealand, South Korea, Switzerland and United Kingdom.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K004027STRYKER REMOTE SURGICAL PLANNING SYSTEM
Stryker Instruments, Jan 24, 2001
K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
Stryker Corp., Jan 18, 2000