GMR40 Retrofit KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815411020298), received between Oct 7, 2017 and Oct 7, 2017 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K171085); 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 18, 2026.

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.

• InjuryOct 7, 2017Structural Problem; Structural Problem

  THE X-RAY TECHNOLOGIST, WHILE TRANSPORTING PORTABLE MACHINE WITH THE RETROFIT EQUIPMENT IN A BACKWARDS MOTION CAUGHT HER LEFT FOOT FROM THE UNDERSIDE OF THE DETECTOR BIN OF THE RETROFIT UNIT WHERE IT SITS CLOSE TO THE FLOOR. THIS CAUSED AN INJURY TO HER FOOT (I.E. BRUISING AND INDUCED PAIN).

  Patient problems: Abrasion; Bruise/Contusion

  MAUDE report 6926628 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171085. One submission often covers many models, so check the product and lot details in each record.

• Z-1391-2018 · Jan 12, 2018 · Terminated
  Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical