| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01127-1 |
| Product Name/Description |
IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system)
Part Number (PN): INS-950093-05
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Intuitive Surgical has identified that the metalized coating on the IS3000 HD Lamp Module (PN INS-950093-05) may be incompatible with the illuminator (PN INS-951183-06) control board, leading to a red Preventive Maintenance Advisory (PMA) that shows up on all monitors and cannot be dismissed by the user. In rare circumstances the illuminator may be damaged or the lamp module might not illuminate. There have been no reports of lamp failures associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising users that this issue does not affect lamps with plastic coating. Affected lamps with metal finish may continue to be used until a replacement is received. If an error message is displayed, users should contact their Device Technologies representative. |
| Contact Information |
1800 429 551 - Device Technologies Australia |