Zero Gravity ZGCM-HSARecalls & reported problems

Tidi Products, LLC · Radiation Protection System Monorail Hinged Swing Arm · Class 1

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00618125176144), received between Feb 7, 2025 and Sep 24, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Puncture/Hole2
Contamination /Decontamination Problem1
Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 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 50892132 ↗
MalfunctionAug 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490528 ↗
MalfunctionFeb 7, 2025Contamination /Decontamination Problem; Detachment of Device or Device Component; Contamination /Decontamination Problem; Detachment of Device or Device Component
ZERO GRAVITY CABLE OUTER SLEEVE IS DAMAGED. IF THE DAMAGE TO THE CABLE OUTER COATING RESULTS IN DEBRIS OR FRAGMENTS THAT MAY THEN FALL INTO THE STERILE FIELD, THIS COULD RESULT IN PATIENT INJURY AND IS THEREFORE MDR REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21339548 ↗

Device details

UDI-DI	`00618125176144`
Brand	Zero Gravity
Model	ZGCM-HSA
Company	Tidi Products, LLC
Product code	EAJ · Apron, Leaded
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Oct 14, 2022

Device type (GMDN): Radiation shielding panel, portable/mobile

A portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

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All Apron, Leaded devices →

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