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Revolution CT- Main Unit (2016-08-23)
- Starting date:
- August 23, 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-60144
Affected Products
Revolution CT- Main Unit
Reason
The following issue is being addressed by GE Healthcare file no. 25470. The Revolution CT exceeds IEC conducted emission requirements. During recent certification testing, GE Healthcare determined that one configuration of the Revolution CT product exceeds the conducted emissions limits specified in the IEC60601-1-2:2007 EMC standard. Medical devices powered on the same power line as the Revolution CT Power Distribution Unit (PDU) may be affected by electrical emissions through the power line. Equipment powered from the CT System such as the EKG Monitor or Patient Contrast Injector is not affected.
Affected products
Revolution CT- Main Unit
Lot or serial number
- 5445060CN7
Model or catalog number
- 55590000
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES