Novarad Corporation: Medical Device Recall in 2020 - (Recall #: Z-2956-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 10, 2019

Date Posted: September 23, 2020

Recall Number: Z-2956-2020

Event ID: 85347

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.

Status: Terminated

Product Quantity: 197 units

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated