—#48465

Product

Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K004027, K993239
Affected lot / code info: All units.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide- USA and countries of Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Mexico, New Zealand, South Korea, Switzerland and United Kingdom.

Timeline

Recall initiated: 2006-09-08
Posted by FDA: 2006-10-03
Terminated: 2007-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48465. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.