InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
FDA device recall Z-0524-2014 · posted 2013-12-17 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
- Action taken
- GE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 654
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-11-26
- Date posted
- 2013-12-17
- Date terminated
- 2017-04-17
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSTATRAK (K960330) | Visualization Technology, Inc. | 1996-04-08 |