ENTrak Plus Navigation and Visualization System
FDA device recall Z-0688-05 · posted 2005-04-08 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
- Action taken
- Customers were notified by letter on 12/13/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 67 units
- Distribution
- Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.
- Date initiated
- 2004-12-13
- Date posted
- 2005-04-08
- Date terminated
- 2011-07-08
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSTATRAK (K960330) | Visualization Technology, Inc. | 1996-04-08 |