NA Head Support (REF BF753)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00724995195885), received between Aug 11, 2022 and Nov 29, 2023 — classified as 5 malfunctions.

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

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

1. 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-0984-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Mechanical Jam; Mechanical Jam

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR DUAL-ARTICULATING HEAD REST LOWERED FROM ITS LOCKED POSITION. THE HEAD REST WAS REPOSITIONED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THE PATIENT WAS TAKEN FOR X-RAYS POST-PROCEDURE AS A PRECAUTION.

  Patient problems: Insufficient Information

  MAUDE report 18234369 ↗
• MalfunctionNov 8, 2023Mechanical Jam; Mechanical Jam

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR DUAL ARTICULATING HEADREST ASSEMBLY WOULD NOT LOCK INTO POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER HEADREST ASSEMBLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094164 ↗
• MalfunctionJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS REPOSITIONING THEIR 4095 SURGICAL TABLE PRIOR TO A PROCEDURE WHEN THEIR FINGERS BECAME CAUGHT BETWEEN THE END RAIL AND THE HEADBOARD ON THE DUAL ARTICULATING HEADREST ASSEMBLY RESULTING IN AN INJURY (CUT). THE EMPLOYEE'S FINGERS WERE RELEASED; IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Laceration(s)

  MAUDE report 17238050 ↗
• MalfunctionNov 4, 2022Use 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 THE TOP TILT FUNCTION WAS ACTIVATED. THE EMPLOYEE'S FINGERS WERE RELEASED, AND THE EMPLOYEE WAS SENT TO URGENT CARE.

  Patient problems: Pain

  MAUDE report 15726693 ↗
• MalfunctionAug 11, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED AN INJURY TO THEIR FINGERS WHILE ADJUSTING THEIR DUAL ARTICULATING HEADREST ASSEMBLY (PINCH/NUMBNESS). THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Numbness

  MAUDE report 15213824 ↗