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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00176-1
Product Name/Description	DX-D100 Mobile Serial Numbers: A5411001012, A5411001212, A5411001213, A5411002010, A5411002168, A5411003095, A5411003118, A5411003175, A5411003176, A5411003177, A5411003178, A5411003262, A5411003317 ARTG 178856 (Agfa Australia Pty Ltd - X-ray generator, diagnostic, mobile)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/03/2024
Responsible Entity	Agfa Australia Pty Ltd
Reason/Issue	Agfa Australia Pty Ltd has identified a potential safety issue related to the steel cable installed inside the 3.1 mobile column which supports the weight of the telescopic arm with the tube head. The potential risk consists of an interference which occurs between the cable and a metal plate of the arm’s carriage due to the shape of the cable’s crimped terminals. No incident related to the potential defect has been reported.
Recall Action	Product Defect Correction
Recall Action Instructions	Agfa Australia will inspect the cable of customer's device at the earliest opportunity and will replace it in case of any potential malfunction of the safety system.
Contact Information	1300 364 612 - Agfa Australia Help Desk