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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01289-1
Product Name/Description	Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield) Zero-Gravity ceiling mounted monorail with hinged swing arm Catalogue Number: 412766 TIDI Part Number: ZGCM-HSA Serial Number: 582023 Zero-Gravity floor unit Catalogue Number: 403803 TIDI Part Number: ZGM-6.5H Serial Number: 549772 Supplied and installed between 28 June 2010 and 31 August 2016 ARTG Number: 221225
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/09/2016
Responsible Entity	Biotronik Australia Pty Ltd
Reason/Issue	The Zero-Gravity Radiation Protection System achieves its nearly weightless support of the body shield by employing a steel cable attached to a balancer. Two reports from users of the system 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-Gravity body shield weighs 25 kg, 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 potentially serious injury.
Recall Action	Recall for Product Correction
Recall Action Instructions	Biotronik will be contacting users and arranging for the replacement of the cable. In addition, the instructions for use and protocols will be updated to include a step to allow the cable to unwind after each use. In the interim, users should inspect the cable for signs of wear or rotational tension that may have created a bend or buckle in the cable. Also, users 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, it is recommended that use is discontinued until the cable is replaced. If facilities continue to use the System until the cable is replaced, they should make sure that they are allowing the unit to go back to its relaxed state. This action has been closed-out on 25/05/2017.
Contact Information	02 9497 3700 - Biotronik Customer Care