RegWardenFDA facility compliance records
Company

NOVARAD CORP.

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2016: 1 recalls; 2019: 1 recalls1’13’141’151’16’17’181’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2019-09-10
    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…
  • Class IITerminated2016-08-12
    Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.
  • Class IITerminated2015-11-16
    The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
  • Class IITerminated2013-05-09
    Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NOVARAD CORP. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9001638-novarad-corp/

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