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Brilliance ICT Systems and Ingenuity CT System (2016-10-12)
- Starting date:
- September 12, 2016
- Posting date:
- November 3, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60804
Affected Products
- Brillance ICT System
- Brillance ICT SP system-Main
- Ingenuity CT system
Reason
The Philips-Granite product label, which is applied by the supplier (Granite) to the rear side of the IMPR (single computer) host cabinet (4598-004-44981), has incorrect current rating label applied. The granite label on the host IMR rack should have electrical rating values of: 230V-2.4 A, 50/60 Hz. The non-conforming label states the current rating as 4.8 A (instead of 2.4 A) , as defined in the host rack IMR specifications.
Affected products
A. Brillance ICT System
Lot or serial number
- 100638
Model or catalog number
- 728306
Companies
- Manufacturer
-
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES
B. Brillance ICT SP system-Main
Lot or serial number
- 200208
- 200213
- 30003
- 30004
- 320227
Model or catalog number
- 728311
Companies
- Manufacturer
-
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES
C. Ingenuity CT system
Lot or serial number
- 30003
- 30004
- 320227
Model or catalog number
- 728323
- 728326
Companies
- Manufacturer
-
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES