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Advantx Legacy/Legacy D R/F System and Prestilix 1600x (2016-11-22)
- Starting date:
- November 22, 2016
- Posting date:
- January 6, 2017
- 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-61554
Affected Products
A. Advantx Legacy/Legacy D R/F System
B. Prestilix 1600x Remote Controlled R&F/RAD/TOMO System
Reason
GE Healthcare has recently become aware of a potential safety issue due to a Distar CRT Monitor that has fallen off the monitor suspension related to product aging. A fall of a CRT Monitor could result in a serious injury to a patient or operator.
Affected products
A. Advantx Legacy/Legacy D R/F System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
S0910JB/JD/JF/JH
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES
B. Prestilix 1600x Remote Controlled R&F/RAD/TOMO System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
S0910JB/JD/JF/JH
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES