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Z-2956-2020 Class II Terminated

Recalled by Novarad Corporation — American Fork, UT

FDA device recall Z-2956-2020 was initiated by Novarad Corporation on September 10, 2019 and is designated Class II. 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 refer… The recall status is terminated (terminated June 30, 2021). Affected quantity: 197 units.

Recall Details

Product Type: Devices
Report Date: September 23, 2020
Initiation Date: September 10, 2019
Termination Date: June 30, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product 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.

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