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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00149-1
Product Name/Description	PRN 50-M+ Digital Writer Part Number: 600-23310-01 Units manufactured from May 28, 2013 through to April 7, 2015 Serial Numbers: 1801405 through 1918761 ARTG Number: 117497
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/02/2016
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	The manufacturer has recently become aware of a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. There is an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer to meet its intended flammability and fluid ingress rating.
Recall Action	Recall for Product Correction
Recall Action Instructions	GE Healthcare is replacing all affected printers with unaffected units. This action has been closed-out on 22/02/2017.
Contact Information	1800 659 465 - GE National Call Centre