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Da Vinci Surgical System - IS3000 and Da Vinci SI System - Vision System Cart (2013-10-23)
- Starting date:
- October 23, 2013
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38241
Recalled Products
Da Vinci Surgical System - IS3000 and Da Vinci SI System - Vision System Cart
Reason
It has been identified that the metalized coating on the IS3000 HD lamp module (Part number: 950093-05) may be incompatible with the illuminator (Part number: 951183-06) control board, leading to an erroneous red preventive maintenance advisory (PMA) that shows up on all monitors and cannot be dismissed by the user. This error does not affect the lighting of the lamp module in the normal fashion, and there are no reports of lamp failure that have been associated with this issue.
Affected products
A. Da Vinci Surgical System - IS3000
Lot or serial number
SH1104
SH1163
SH1184
SH1319
Model or catalog number
IS3000
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES
B. Da Vinci SI System - Vision System Cart
Lot or serial number
273456
275654
280258
292610
Model or catalog number
VS3000
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES