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HFD100 Rocker Arm AccessoryRecalls & reported problems

IMRIS Imaging, Inc. · Rocker Arm Accessory Kit HFD100, 117948-000 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857534006264), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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

Device problems

  • Component or Accessory Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 3, 2022Component or Accessory Incompatibility; Component or Accessory Incompatibility

    DURING A PEDIATRIC SURGICAL PROCEDURE ON (B)(6) 2019, IT WAS DETERMINED BY AN OR STAFF THAT THE HFD100 ROCKER ARM COULD NOT BE TIGHTENED. THE ROCKER ARM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13441802 ↗

Other Holder, Head, Neurosurgical (Skull Clamp) devices

All Holder, Head, Neurosurgical (Skull Clamp) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.