| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00224-1 |
| Product Name/Description |
ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)
Affected Serial numbers: 75659, 75804, 76126, 75805, 76116, 12008, 72902, 76009, 12043, 12036, 75657, 75658 and 12015
ARTG: 126243 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has determined there is potential for the keyboard to lockup during operation due to a software issue in the VP1600 console. If during use the CAPS Lock/NUM Lock is pressed, the VP1600 software could potentially give the appearance of being locked up, but is actually unresponsive only to keyboard inputs. The VP1600 is still presenting a live image on the main display but may not be able to capture an image frame for record storage using the keyboard. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Please contact ConMed Linvatec Australia to schedule a return date for repairing the affected unit. A loan unit will be provided by ConMed Linvatec if needed during the repair. VP1600 can continued to be used until repaired if the manufacturer’s recommendations and instructions detailed in the Product Manual, for the safe handling and use of the device is followed. |
| Contact Information |
1800 238 238 - ConMed Linvatec Australia |