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EXTENDED BRILLIANCE WORKSPACE NM (2016-03-08)
- Starting date:
- March 8, 2016
- Posting date:
- March 17, 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-57580
Affencted Products
EXTENDED BRILLIANCE WORKSPACE NM
Reason
The AutoSPECT Pro Application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90? or 180? relative to one another. However, certain gamma cameras, e.g., the Marconi AXIS and IRIX cameras, permit acquisitions at other relative detector angles. Philips has become aware that data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro, and the results will likely be erroneous.
Affected products
EXTENDED BRILLIANCE WORKSPACE NM
Lot or serial number
ALL
Model or catalog number
459800090831
Companies
- Manufacturer
-
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES