IS3000, Redundant Medical Grade Power Supply, Reduced Fan Speed (2018-07-16)
- Starting date:
- July 16, 2018
- Posting date:
- August 2, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device, Biologic/vaccine
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67338
Affected products
IS3000, Redundant Medical Grade Power Supply, Reduced Fan Speed
Reason
There is an increase in Redundant Medical Grade Power Supply (RMGPS) failures. This is due to a miswiring where the Control/Status and Output wires from the two power supply modules are crossed at the combiner board. If there is an independent failure of one of the power supply modules, the RMGPS shuts down the functioning module, perceiving that it is the failed module due to the crossed wires.
Affected products
IS3000, Redundant Medical Grade Power Supply, Reduced Fan Speed
Lot or serial number
- RSH0112 (Serial Number)
- RSH0201 (Serial Number)
- SD0009 (Serial Number)
- SK1421 (Serial Number)
Model or catalog number
IS3000
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101,
Sunnyvale
94086
California
UNITED STATES