Class 2 Device Recall ZeroGravity Radiation Protection System

• Date Initiated by Firm: September 09, 2016
• Date Posted: October 13, 2016
• Recall Status: Terminated on August 25, 2017
• Recall Number: Z-0080-2017
• Recall Event ID: 75240
• Product Classification: Apron, leaded - Product Code EAJ
• Product: Zero-Gravity Radiation Protection System; Radiology; Personnel protective shield.
• Code Information: 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
• Recalling Firm/ Manufacturer: Contour Fabricators Inc; 14241 N Fenton Rd; Fenton MI 48430-1541
• For Additional Information Contact: Lisa Huntley; 810-593-3240
• Manufacturer 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.
• FDA Determined 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.)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.