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