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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00507-1
Product Name/Description Laser photocoagulator Easyret software version 1.03

Product Code: QM-PABX0017

Serial Number: 155

ARTG Number: 130657
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 21/04/2017
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue The manufacturer Quantel Medical has become aware of an issue with the MicroPulse mode of the Easyret laser (QM-PABX0017, Serial Number 155) in software version 1.03. If the validation key of the intermediate window for treatment lens and spot size selection is pressed twice when selecting the MicroPulse mode, a software bug leading to the delivery of an erroneous level of energy corresponding to a 100% duty cycle when in treatment session will be created. This issue could cause photocoagulation of the retina in patients.
Recall Action Recall for Product Correction
Recall Action Instructions Device Technologies Australia (DTA) is advising users to discontinue use of the MicroPulse mode on the device until the software update in version 1.04 has been completed by a DTA representative.
This action has been closed-out on 15/03/2018.
Contact Information 07 3623 1498 - Device Technologies