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REVOLUTION CT - MAIN UNIT (2015-10-26)
- Starting date:
- October 26, 2015
- Posting date:
- June 16, 2016
- 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-58892
Affected products
- REVOLUTION CT - MAIN UNIT
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
A. REVOLUTION CT - MAIN UNIT
Lot or serial number
- 00000437461CN7
- 00000443398CN3
- 440186CN5
- 441961CN0
- 442082CN4
- 442220CN0
- 442268CN9
- 442492CN5
- 442573CN2
- 443398CN3
Model or catalog number
- 5590000
Companies
- Manufacturer
- GE Medical Systems LLC