Head rest 113053B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046768002500), received between Dec 19, 2024 and Dec 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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

Recent adverse event reports

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

• MalfunctionDec 19, 2024Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement

  GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR ACCESSORIES 113053B0 - HEAD REST WITH DOUBLE ARTICULATION USED WITH 113112B0 - BETASTAR MOBILE OPERATING TABLE. IT WAS STATED THAT THE HEADREST OF THE SURGICAL TABLE DETACHED IN THE MIDDLE OF SURGERY, CAUSING CERVICAL HYPEREXTENSION IN THE PATIENT. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND ASSESSED FOR CERVICAL DAMAGE AND LIMB MOBILITY. THE PATIENT WAS THEN RE-ANESTHETIZED AND THE PROCEDURE CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE HEADREST DETACHMENT CAUSING THE HYPEREXTENSION IN THE PATIENT¿S NECK, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20976639 ↗