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Lightspeed 16 CT Scanner and Discovery PET/CT 600 Systems (2016-02-05)
- Starting date:
- February 5, 2016
- Posting date:
- February 12, 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-57102
Affected Products
- LIGHTSPEED 16 CT SCANNER SYSTEM
- DISCOVERY PET/CT 600 SYSTEM
Reason
GEHC has updated the service manuals used to maintain these scanners to fix an incorrect torque value, which is the source of the field action. FMI 25463 identified a torque issue with 5 volt supplies in CT and PET LightSpeed systems and corrected the issue by field action, as well as a technical manual update. This recall is to send a second customer letter to anyone who may still possess and use an obsoleted service manual.
Affected products
A. LIGHTSPEED 16 CT SCANNER SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
B7868JA
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES
B. DISCOVERY PET/CT 600 SYSTEM
Lot or serial number
- 00000348810CN3
- 00000349405CN1
Model or catalog number
S9118JS
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES