Z-0080-2017Class II

Zero-Gravity Radiation Protection System Radiology Personnel protective shield

Name: Z-0080-2017 Zero-Gravity Radiation Protection System Radiology Personnel protective shield
Creator: Contour Fabricators Inc
Published: 2016-09-09
License: https://open.fda.gov/license/

Domico Med-Device, LLC / initiated 2016-09-09 / Terminated / root cause: labeling and UDI

FDA source

Contour Fabricators Inc began a recall of Zero-Gravity Radiation Protection System Radiology Personnel protective shield on 2016-09-09. FDA classified it as Class II and gives the reason as "Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0080-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-09
Posted: 2016-10-13
Terminated: 2017-08-25
Recalling firm: Domico Med-Device, LLC
Product: Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
Product code: EAJ Apron, Leaded
Reason for recall: Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 9/9/2016, URGENT: MEDICAL DEVICE CORRECTION letters dated 9/8/2016 were sent to the affected consignees via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. TIDI Products is taking the following action to correct this issue: 1. Revising instructions for use to include the step to allow the cable to unwind after use and prior to storing the body shield in a locked or secured position. 2. Modifying user and staff training protocols to include the requirement to allow the cable to unwind after each use. 3. Adding additional warning labels to the system. 4. Replacing all cables in the field to ensure that any potentially stressed cable is removed. A representative from TIDI Products will be contacting you to schedule a visit from a technician to implement this corrective action. Customer Actions Cables should be carefully inspected for signs of wear or rotational tension, which will create a bend or buckle in the cable. Practitioners and medical institutions should review their routine use of the Zero-Gravity Radiation Protection System to determine if the body shield undergoes repeated rotation without allowing the cable to relax back to its normal condition. If the cable has been consistently rotated in one direction without being allowed to relax back to its normal condition or if there is any doubt about excessive rotation in one direction, TIDI recommends that practitioners and medical institutions discontinue use until such time as corrective action can be implemented by TIDI Products. If facilities continue to use their Zero-Gravity" Radiation Protection System until correction and install of the replacement cable can be performed, they should make sure that they are allowing the unit to go back to its relaxed state. Please complete and return the enclosed response for
Quantity in commerce: 447
Distribution: Nationwide. Canada. AUSTRALIA AUSTRIA BELGIUM BRUNEI CHINA FRANCE GERMANY INDA INDONESIA ISRAEL ITALY KSA MALAYSIA NETHERLANDS POLAND QATAR QUEBEC SAUDI ARABIA SINGAPORE SOUTH AFRICA TAIWAN (R.O.C.)
Product codes and lots: All serial numbers for all models listed below manufactured/distributed between June 28, 2010 August 25, 2016. Part No. : Description ZGM-6-.5H : Zero-Gravity floor unit ZGM-6-5ROUNDH : Zero-Gravity floor unit ZGM-6Demo : Zero-Gravity demo floor unit ZGCM-48 : Zero-Gravity ceiling mounted monorail with 48 boom arm ZGCM-48-SPECIAL : Zero-Gravity ceiling mounted monorail with 48 boom arm with monorail extension ZG48 : Zero-Gravity 48 boom arm assembly and body shield for monorail ZGCM-66 : Zero-Gravity ceiling mounted monorail with 66 boom arm ZGCM-HSA : Zero-Gravity ceiling mounted monorail with hinged swing arm ZGCH : Zero-Gravity ceiling mounted monorail Contour track with 48 boom arm ZGCH48 : Zero-Gravity 48 boom arm assembly and body shield for Contour track ZGHSA : Zero-Gravity single point, ceiling mount with hinged swing arm ZGCSP : Zero-Gravity single point, ceiling mount with hinged swing arm 29858 : Zero-Gravity floor unit

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0080-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0080-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code EAJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)