NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
FDA device recall Z-1613-2016 · posted 2016-05-06 · Terminated
Recall details
- Recalling firm
- Novarad Corporation
- Reason for recall
- The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
- Action taken
- Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2,386
- Distribution
- Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
- Date initiated
- 2015-11-16
- Date posted
- 2016-05-06
- Date terminated
- 2016-08-17
- Location
- American Fork, UT
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVAPACS (K132853) | Novarad Corp. | 2014-10-30 |