| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01053-1 |
| Product Name/Description |
Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes
Multiple FUJINON G5 and G8 Type Flexible GI Endoscope series affected
ARTG Number: 112590 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia (DTA) in conjunction with the manufacturer is informing users of an important change in the Instructions For Use (IFU) for the Reliance Endoscope Processing System (EPS) when processing specific FUJINON G5 and G8 type flexible GI endoscopes. When set up as defined in the IFU the air pipe on specific Fujinon endoscopes doesn’t receive forced flow during the processing cycle. A new STERIS Flow unit 7 has been developed to facilitate forced flow of high level disinfecting solution through the air pipe and is required for Reliance EPS processing of any impacted Fujinon devices. A new “Quick Reference Guide” has been developed to incorporate these changes. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is providing their customers with a new “Quick Reference Guide” and requesting that reprocessing G5 and G8 type endoscopes is discontinued until the correct flow unit #7 is provided. |
| Contact Information |
1800 429 551 - Device Technolgies |