Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00405-1
Product Name/Description	ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems ARTG Number: 117642
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	1/04/2014
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Philips Healthcare received a report from the field about an ADAC Vertex Plus system. During clinical use in the relative 180 degree configuration of the detector heads, the radius drive belt in the superior positioned head slipped off the idler pulley, allowing the detector head to drift down slowly (approximately 1 cm per minute) towards the patient. This resulted in the operator having to perform an emergency removal of the patient from the system. There have been no reports of serious injury or death as a result of this situation.
Recall Action	Recall for Product Correction
Recall Action Instructions	Hospitals are requested to cease use of "Relative 180 degree SPECT" and "pinhole collimator" procedures until the implementation of the correction. Philips will replace the two radius drive belts and idler pulleys to correct the problem.
Contact Information	1800 251 400 - Philips Customer Care Centre