NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Reported: May 18, 2016 Initiated: November 16, 2015 #Z-1613-2016
Product Description
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Reason for Recall
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
Details
- Recalling Firm
- Novarad Corporation
- Units Affected
- 2,386
- Distribution
- Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
- Location
- American Fork, UT
Frequently Asked Questions
What product was recalled? ▼
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation. Recalled by Novarad Corporation. Units affected: 2,386.
Why was this product recalled? ▼
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Moderate. Recall number: Z-1613-2016.
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