vRad PACS 2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00862234000313), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 death.

The most frequently reported specific device problem is “Intermittent Program or Algorithm Execution” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 9, 2023Open, Classified

   The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

   Z-2235-2023 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 3, 2026Intermittent Program or Algorithm Execution

  ON (B)(6) 2023, A RADIOLOGIST USING VRAD PACS WITH MAMMOGRAPHY EXPERIENCED AN INTERMITTENT SOFTWARE ANOMALY. THE SOFTWARE ANOMALY RESULTED IN PATIENT'S CURRENT RADIOLOGICAL IMAGE TO NOT LAUNCH, INDICATED BY A PERSISTENT "LOADING" MESSAGE DISPLAYED TO THE RADIOLOGIST USER. THE RADIOLOGIST THEN LAUNCHED A PRIOR STUDY (INDICATED BY A "COMPARISON" LABEL ON THE IMAGE), BYPASSING SEVERAL VISUAL CUES AND CONVENTIONS. THE RADIOLOGIST RENDERED AN INTERPRETATION BASED ON HISTORIC IMAGES THAT DID NOT CAPTURE THE PATIENT'S CURRENT, CRITICAL CONDITION, AND THE INTERPRETATION WAS SUBMITTED TO THE LOCAL TREATING FACILITY. ON 20-MAY-2023, VRAD LEARNED THE PATIENT DIED EARLIER IN THE MONTH.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24776400 ↗