| 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 |
|
| 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 |