RADspeed Pro 503-79460-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04540217052479), received between Aug 22, 2019 and Dec 2, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K152244); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE, THE X-RAY TUBE SUPPORT SECTION OF THE CEILING TYPE X-RAY TUBE SUPPORT CAME OFF THE X-RAY TUBE SUPPORT PULL-UP SECTION, AND THE TECHNICIAN SUPPORTED THE X-RAY TUBE SUPPORT SECTION AND LOWERED IT TO THE FLOOR. THE PATIENT WAS NOT INJURED. WE HAVE RECEIVED REPORTS THAT HAD STRAINED SHOULDER WHEN THE TECHNICIAN LOWERED THE X-RAY TUBE SUPPORT SECTION TO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902781 ↗
• MalfunctionJul 1, 2020Application Program Problem

  THE X-RAY CONDITION CHANGED WITHOUT ANY OPERATION. THE OPERATOR TOOK AN X-RAY WITHOUT NOTICING ANY CHANGE IN THE X-RAY CONDITION.

  Patient problems: Radiation Overdose

  MAUDE report 10216524 ↗
• MalfunctionJul 1, 2020Therapeutic or Diagnostic Output Failure

  THE X-RAY CONDITION (MAS) CHANGED WITHOUT ANY OPERATION. IT HAS NOT BEEN REPORTED THAT X-RAY IMAGES WERE TAKEN IN THE POST-CHANGE X-RAY CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10216523 ↗
• MalfunctionAug 22, 2019Problem with Software Installation; Problem with Software Installation

  TECHNICIAN SAID SHE TOOK A RADIOLOGICAL IMAGE ON THE UPRIGHT WALL STAND AND RECEIVED NO IMAGE AFTER PRODUCING X-RAY. CORRECTIVE ACTION DID NOT RECOVER A PATIENT IMAGE.

  Patient problems: Radiation Overdose

  MAUDE report 8924010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152244. One submission often covers many models, so check the product and lot details in each record.

• Z-2294-2026 · Apr 20, 2026 · Open, Classified
  Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D1
• Z-2654-2017 · May 23, 2017 · Terminated
  SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system