Contour Fabricators Inc: Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

Recall number

Z-0080-2017

Recalling firm

Contour Fabricators Inc

Product

Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

Status

Terminated

Initiated

2016-09-09

Posted

2016-10-13

Terminated

2017-08-25

Reason

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

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

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.)

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

EAJ

Firm FEI

1825560

Firm city

Fenton

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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