Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050
FDA device recall Z-1389-05 · posted 2005-08-23 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
- Action taken
- U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZJ
- Quantity affected
- 25
- Distribution
- Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,
- Date initiated
- 2005-08-05
- Date posted
- 2005-08-23
- Date terminated
- 2005-10-26
- Location
- Kalamazoo, 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 CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K040369) | Stryker Instruments | 2004-04-01 |