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LEGACY AND PRECISION DIGITAL R/F SYSTEMS (2015-06-22)
- Starting date:
- June 22, 2015
- Posting date:
- July 17, 2015
- 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-54228
Affected Products
A. ADVANTX LEGACY/LEGACY D R/F SYSTEM
B. PRECISION 500D SYSTEM
Reason
The SFD/IDD safety mechanism installed on the system may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1" (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator. There have been no reported injuries as a result of this issue.
Affected products
A. ADVANTX LEGACY/LEGACY D R/F SYSTEM
Lot or serial number
> 10 lot numbers, contact mfg
Model or catalog number
2258627
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
B. PRECISION 500D SYSTEM
Lot or serial number
> 10 lot numbers, contact mfg
Model or catalog number
2403791
2403791-3
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES