NovaPACS Diagnostic Viewer versions 8.3.7 recall
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Why was NovaPACS Diagnostic Viewer versions 8.3.7 recalled?
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4
- Product
- NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
- Recalling firm
- Novarad Corporation
- Quantity
- 2,386
- Distribution
- Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
- Recall date
- May 18, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)