Zero Gravity ZGM-6-5HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00618125176250), received between Feb 3, 2023 and Sep 24, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891981 ↗
• MalfunctionMar 18, 2026Unintended Movement

  THE SCREWS WERE SHEARED OFF WHEN MOVING THE UNIT BY UNKNOWN AND THE BOOM ARM ROTATED INJURING 2 PEOPLE (UNKNOWN WHO AND WHAT INJURY) BUT DID NOT MENTION THE UNIT TIPPING OVER.

  Patient problems: Insufficient Information

  MAUDE report 24628623 ↗
• MalfunctionFeb 11, 2026Fracture

  1/15/26-CUSTOMER ASKED FOR QUOTE TO REPLACE THE ZERO GRAVITY BODY SHIELD AS IT DID NOT PASS THE X-RAY CHECK AS IT WAS DISCOVERED THAT THERE IS A LARGE SPLIT IN THE LEAD MODEL: ZGM-6-5H SERIAL#: (B)(6) MANUFACTURED 11-2016

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318649 ↗
• MalfunctionDec 30, 2025Mechanical Problem; Mechanical Problem

  CUSTOMER ASKED FOR QUOTE FOR A REPLACEMENT ZG BALANCER, SHE STATED THERE IS SOME RESISTANCE WHEN YOU ARE TRYING TO RETRACT THE LEAD APRON. NO DAMAGE TO THE SHEATHING AROUND THE CABLE NOTICED BY THE CUSTOMER. CABLE WAS UPGRADED ON 2/12/21 MODEL: ZGM-6-5H, SERIAL#: (B)(6), MANUFACTURED 3-2014.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23929577 ↗
• InjuryJul 1, 2025Inadequate or Insufficient Training; Device Handling Problem; Inadequate or Insufficient Training; Device Handling Problem

  2 STAFF MEMBERS GOT INJURED TRYING TO MOVE A ZG FLOOR SYSTEM. THE 2 EMPLOYEES HAVE NO EXPERIENCE WITH ZERO GRAVITY AND ATTEMPTED TO MOVE THE SYSTEM WITHOUT THE APPROPRIATE TRAINING ACCORDING TO THE CONTACT AT THE HOSPITAL. THE SYSTEM HASN'T BEEN USED FOR QUITE SOME TIME SO THERE IS A LACK OF KNOWLEDGE ON HOW TO MOVE AND USE THE DEVICE. THERE WERE NO REPORTS OF THE SYSTEM BEING DEFECTIVE. EMPLOYEE 1 SUSTAINED A SERIOUS TOE INJURY DUE TO THE SYSTEM ROLLING/PUSHED OVER HER TOE. THE 2ND EMPLOYEE SUSTAINED A CALF STRAIN TRYING TO PUSH THE ZERO GRAVITY. BUTLER WAS INFORMED THAT TIDI WOULD SEND SOMEONE THERE TO DO AN IN-SERVICE AND TRAIN THEM HOW TO MOVE AND OPERTATE THE SYSTEM.

  Patient problems: Bruise/Contusion; Cramp(s) /Muscle Spasm(s)

  MAUDE report 22378223 ↗
• InjuryApr 19, 2024Unintended Movement; Unintended Movement

  ZERO GRAVITY MOBILE SYSTEM TIPPED OVER. THE EXACT DATE IS CURRENTLY UNKNOWN. INFORMATION WAS PROVIDED BY THE DISTRIBUTOR, BIOTRONIK. THIS IS THE FIRST INCIDENT; THE SYSTEM TIPPED OVER INJURING / BREAKING A LADY'S FOOT WHEN MOVING THE UNIT. THE SECOND INCIDENT OCCURRED WHEN THE UNIT BEGAN TO TIP OVER, HOWEVER IT WAS CAUGHT BY THE PERSON MOVING THE SYSTEM AND DID NOT FULLY FALL OVER. NO INJURIES WERE REPORTED FOR THE SECOND INCIDENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19149317 ↗
• MalfunctionJun 9, 2023Corroded; Corroded

  5/16/23- THE SWIVEL ASSEMBLY IS RUSTED. MODEL: ZGM-6-5H SERIAL#: (B)(6) MANUFACTURED 2017.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100955 ↗
• InjuryFeb 3, 2023Unintended Movement; Unintended Movement

  INFORMED VIA PHONE CALL BY THE BIOTRONIK DISTRIBUTOR THE FOLLOWING INFORMATION: ORIGINAL PRODUCT FAILURE WAS NOT REPORTED TO TIDI OR BIOTRONIK - POSSIBLE BROKEN SCREW IN STOP BLOCK. REPAIRED PERFORMED BY CUSTOMER BIOMED. WHILE MOVING THE UNIT BEFORE OR AFTER THE REPAIR, IT FELL OVER. THE PERSON DOING THE MOVING OF SYSTEM HAS REPORTED A SORE BACK.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 16296618 ↗