NA GU60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08806088566313), received between May 1, 2017 and Oct 7, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2017Thermal Decomposition of Device; Device Emits Odor

  CUSTOMER REPORTED BURNING SMELL COMING FROM THE PORTABLE UNIT. SERVICE ARRIVED ON SITE AND INSPECTED THE POWER SUPPLY AND FOUND MULTIPLE BURNED COMPONENTS ON THE STANDALONE PCB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6926643 ↗
• InjuryMay 1, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A PATIENT WAS POSITIONED (SUPINE) ON THE PATIENT SUPPORT AWAITING THE PRESCRIBED SCAN. AS THE X-RAY TUBE WAS DESCENDING TOWARDS THE PATIENT TO GET INTO POSITION (WHEREIN THE TUBE MUST BE CLOSE TO THE PATIENT), THE PATIENT MOVED OUT OF THE WAY AND ROLLED HIMSELF OFF OF THE TABLE.

  Patient problems: Injury

  MAUDE report 6535319 ↗