NA Head Support (REF BF754)Recalls & reported problems
Steris Corporation · The Dual Articulating Headrest with Mushroom Cap is used with the 5085 Harmony, 4095 and 5095 STERIS General Surgical Tables. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995197643), received between Sep 27, 2023 and Sep 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 12, 2023Open, Classified
Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
Z-0983-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2023Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE INADVERTENTLY PINCHED THEIR FINGERS BETWEEN THE HEADBOARD AND END RAIL ON THEIR DUAL ARTICULATING HEADREST ASSEMBLY WHEN ATTEMPTING TO REMOVE THE HEADREST FROM THE TABLE. THE EMPLOYEE'S FINGERS WERE RELEASED, AND THE EMPLOYEE WAS SENT TO THE EMERGENCY DEPARTMENT. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED. REPORT OF PROCEDURE DELAY.
Patient problems: Pain
MAUDE report 17826575 ↗
Other HEADREST, NEUROSURGICAL devices
- NA Head SupportSteris Corporation · HEADREST, NEUROSURGICAL1 recall5 reports
- MAYFIELD® A1012Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL6 reports
- MAYFIELD® A1051Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL5 reports
- DORO® Base Unit 3001-00Black Forest Medical GmbH · Headrest, Neurosurgical3 reports
- DORO® Adaptor 3002-00Black Forest Medical GmbH · Headrest, Neurosurgical2 reports
- MAYFIELD® A1112Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL1 report
- MAYFIELD® A1011Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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