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Discovery PET/CT 710 System (2013-11-22)
- Starting date:
- November 22, 2013
- Posting date:
- January 6, 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-37297
Recalled products
- Discovery PET/CT 710 System
Reason
A software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and over-correction. Reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. This issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions. This defect may lead to misinterpretation of the image and/or inaccurate treatment decisions.
Affected products
A. Discovery PET/CT 710 System
Lot or serial number
- Not applicable
Model or catalog number
- 5856030-X
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES