RegWardenFDA facility compliance records
Facility

NOVARAD CORP.

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2016: 1 recalls, 1 inspections; 2019: 1 recalls1’13’141’152’16’17’181’19’20’21’22’23’24’25’26
  • Recalls (4)
  • Inspections (1)

Devices registered here (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.

FDA inspections (1)

  • VAI2016-03-30
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NOVARAD CORP. (FEI 1000117423) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000117423-novarad-corp/

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