NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software tha...
FDA Device Recall #Z-2956-2020 — Class II — September 10, 2019
Recall Summary
| Recall Number | Z-2956-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 10, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Novarad Corporation |
| Location | American Fork, UT |
| Product Type | Devices |
| Quantity | 197 units |
Product Description
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
Reason for Recall
The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Colombia, Dominican Republic, Indonesia, Jordan, Mexico, Peru, Phillipines, and United Kingdom.
Lot / Code Information
NovaPACS versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8
Other Recalls from Novarad Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2659-2016 | Class II | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Dist... | Aug 12, 2016 |
| Z-1613-2016 | Class II | NovaPACS Diagnostic Viewer versions 8.3.7, 8.... | Nov 16, 2015 |
| Z-2151-2016 | Class II | NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Dia... | May 9, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.