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LIGHTSPEED 16 CT SCANNER SYSTEM (2015-07-22)
- Starting date:
- July 22, 2015
- Posting date:
- August 10, 2015
- 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-54564
Affected Products
A. LIGHTSPEED 16 CT SCANNER SYSTEM
Reason
The three mounting bolts securing the power supply could have been over-torqued due to a service procedure error. In the unlikely event that the component becomes loose on the CT gantry during operation t could result in serious bodily injury if the component were to be expelled.
Affected products
A. LIGHTSPEED 16 CT SCANNER SYSTEM
Lot or serial number
- 298660CN2
- 307018CN2
- 318927CN1
- 329994CN8
- 335314CN1
- 389961CN4
Model or catalog number
- B7868JA/JD
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES