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Advantx Legacy and Precision 500D System (2013-09-04)
- Starting date:
- September 4, 2013
- Posting date:
- June 12, 2014
- 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-39977
Recalled products
- Advantx Legacy System
- Precision 500D system
Reason
There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the on position. These conditions could cause the system to strike the patient.
Affected products
A. Advantx Legacy System
Lot or serial number
Not applicable
Model or catalog number
- S0910JB
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES
B. Precision 500D system
Lot or serial number
Not applicable
Model or catalog number
- 2403791
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES