Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000
FDA device recall Z-0006-2007 · posted 2006-10-03 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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.
- Date initiated
- 2006-09-08
- Date posted
- 2006-10-03
- Date terminated
- 2007-12-04
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER REMOTE SURGICAL PLANNING SYSTEM (K004027) | Stryker Instruments | 2001-01-24 |
| STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX (K993239) | Stryker Corp. | 2000-01-18 |