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Brilliance CT Big Bore System-Main Unit (2013-09-03)
- Starting date:
- September 3, 2013
- Posting date:
- September 27, 2013
- 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-35911
Recalled products
A. Brilliance CT Big Bore System-Main Unit
Reason
There are artifacts appearing on the tracker images during threshold-triggered bolus scans with protocols using a rotation time of 0.4 seconds. In those cases only, the scan might be triggered either too soon or too late, which may lead to inappropriate contrast opacification during the clinical scan. If the acquired images are not diagnostically acceptable, a rescan of the patient may be performed.
Affected products
Brilliance CT Big Bore System-Main Unit
Lot or serial number
Serial Numbers:
- 7852
- 7877
- 7891
- 7910
- 7928
- 7841
Model or catalog number
- 4535 670 88051
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES