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Revolution CT (2015-10-26)
- Starting date:
- October 26, 2015
- 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-55774
Affected Products
Revolution CT
Reason
A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.
Affected products
Revolution CT
Lot or serial number
- 00000437461CN7
- 00000443398CN3
- 441961CN0
- 442082CN4
- 442220CN0
- 442268CN9
Model or catalog number
5590000
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES