MR/X-ray HFD (HFD 200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857534006028), received between Feb 2, 2022 and Mar 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K113748); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  DURING ROUTINE PREVENTIVE MAINTENANCE, AN IMRIS SERVICE ENGINEER OBSERVED A BROKEN SCREW HEAD ON A COMPONENT OF THE HFD200 DEVICE. THE SUBJECT SCREW CONNECTS TO A SKULL PIN SOCKET AND THE HFD200'S EXTENSION ASSEMBLY. IT IS UNKNOWN WHEN THE SCREW HEAD BROKE; THERE WAS NO PATIENT INVOLVED WHEN THE ISSUE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13744197 ↗
• MalfunctionFeb 6, 2022Break; Misassembly by Users; Material Split, Cut or Torn; Break; Misassembly by Users; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING REASSEMBLY AFTER CLEANING, THE THREADED DRIVE ROD OF THE HFD200 HEAD FIXATION DEVICE BROKE. AT THE TIME THE DRIVE ROD BROKE, A HOSPITAL STAFF MEMBER WAS DEMONSTRATING HOW TO REASSEMBLE THE DEVICE AND MAY HAVE OVER-TORQUED THE DRIVE ROD DURING REASSEMBLY. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467511 ↗
• MalfunctionFeb 2, 2022Device Slipped; Device Slipped

  ON (B)(6) 2018, A PATIENT UNDERWENT A CERVICAL PROCEDURE USING INTRAOPERATIVE COMPUTED TOMOGRAPHY (ICT) WITH IMAGE GUIDANCE. THE PATIENT WAS POSITIONED IN THE PRONE POSITION AND THE TORQUE ON THE DRIVE KNOB WAS SET AT 60IBS. THE HFD200 WAS CONNECTED TO LINKAGE ON THE TABLE AND THE PATIENT'S BODY WAS PADDED APPROPRIATELY. DURING TRANSFER AND INITIAL CONNECTION TO LINKAGE OF HFD200, THE SURGICAL STAFF DID NOT NOTICE CHANGE IN HEAD POSITION, MOVEMENT OF THE ROCKER ARM, OR FORCE APPLIED TO THE FIXATION FRAME. THE PROCEDURE WAS SUCCESSFUL AND AFTERWARDS, SUTURES AND GAUZE WAS PLACED ON THE PATIENT'S CERVICAL PRONE AREA WHERE THE INCISION WAS PERFORMED.THE HFD200 WAS DISCONNECTED AND THE PATIENT WAS ROLLED FROM THE PRONE POSITION TO SUPINE TO STOP ANESTHESIA. AFTER REMOVING THE PATIENT FROM THE HFD200, A 5CM LACERATION WAS OBSERVED BEHIND THE PATIENT'S EAR ON THE SIDE WHERE THE ROCKER ARM WAS POSITIONED. THE OPERATING ROOM STAFF TESTED THE ROCKER ARM AFTER THE SURGERY AND IT FUNCTIONED AS INTENDED. THE LACERATION REQUIRED SUTURES TO CLOSE.

  Patient problems: Laceration(s)

  MAUDE report 13425764 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113748. One submission often covers many models, so check the product and lot details in each record.

• Z-0163-2020 · Jun 26, 2019 · Terminated
  IMRIS MR/X-ray head fixation device, Model HFD200