HC150 - 1.5T Head Coil Lower Assy HC150 Lower AssyRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857534006240), received between May 21, 2022 and May 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMay 21, 2022Break; Intermittent Continuity; Loose or Intermittent Connection; Break; Intermittent Continuity; Loose or Intermittent Connection

  ON (B)(6) 2022, IT WAS REPORTED THAT AN IMRIS LOWER FLEX COIL FAILED TO FUNCTION WHEN USED FOR INTRA-OPERATIVE MR IMAGING. THE NEUROSURGEON HAD REQUESTED AN INTRA-OPERATIVE BRAIN SCAN AFTER TUMOR REMOVAL AND A SYSTEM ERROR MESSAGE WAS PRODUCED WHEN THE LOWER FLEX COIL WAS PLUGGED IN. THE MR MAGNET WAS RETURNED TO HOME POSITION, POWER CYCLED, AND THEN RETURNED TO THE OPERATING ROOM; HOWEVER, THIS DID NOT RESOLVE THE ERROR. THE COIL WAS UNSUCCESSFULLY PLUGGED INTO A DIFFERENT PORT AS WELL. THE UPPER FLEX COIL WAS THEN MOVED TO THE LOWER POSITION, AND A WIRELESS INSITU COIL WAS USED IN THE UPPER POSITION, AND IMAGING WAS THEN SUCCESSFULLY OBTAINED. THE PATIENT WAS UNDER EXTENDED ANESTHESIA FOR APPROXIMATELY TWO HOURS AT THE SURGEON'S DISCRETION DURING TROUBLESHOOTING BEFORE THE IMAGING WAS PRODUCED. THE IMAGING RESULTS CONFIRMED THERE WAS NO REMAINING TUMOR TO RESECT, AND NO PATIENT HARM WAS REPORTED AS A RESULT OF THE DELAY OR EXTENDED TIME UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465859 ↗