RegWardenFDA facility compliance records
Company

Intelerad Medical Systems Incorporated

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

Recalls by year

FDA actions on record by year2014: 1 recalls; 2025: 2 recalls1’14’15’16’17’18’19’20’21’22’23’242’25’26
  • Recalls (3)

Registered facilities (4)

Recalls & enforcement

  • Class IIOngoing2025-10-17
    Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Refe…
  • Class IIOngoing2025-02-05
    A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which…
  • Class IITerminated2014-07-03
    In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is pa…

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. “Intelerad Medical Systems Incorporated — 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-9040757-intelerad-medical-systems-incorporated/

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