| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01276-1 |
| Product Name/Description |
Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000
Catalogue Number: C7002
Lot Numbers: 1885744, 1923802, 1985221, 2057996, 2109587 and 2118507
ARTG Number: 283158 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Integra Neurosciences has been advised that certain lots of footswitch supplied with the CUSA Clarity Console may be faulty.
A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios during which the failure mode may occur:
1. Ultrasonic fragmentation may be activated after set-up is complete and the user goes to the Main Screen (without the footswitch pressed); and/or
2. Ultrasonic fragmentation may remain activated during surgical use once the footswitch Amplitude pedal is disengaged.
There have been no adverse events or injury reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Integra is advising users to quarantine the affected units from use. Affected units will be replaced with unaffected stock.
This action has been closed out on 19/09/2018 |
| Contact Information |
1300 550 599 - Integra Customer Service |