Device product
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Z-1505-2016
Product summary
- Event
- Event 73776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37 Units
- Official record key
device-enforcement:Z-1505-2016
Official wording
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 allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
Code information: M/N 882488; S/N: 66565, 66586, 66589, 66670, 66681, 66672, 66644, 66888, 66374, 66371, 66305, 66824, 66261, 66356, 66059, 66056, 67027, 66248, 66590, 66240, 66097, 66268, 66555, 66500, 66754, 66469, 66411, 66252, 66263, 66307, 66311, 66310, 66306, 66259, 67054, 67000 & 67017.
Distribution pattern: Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
Derived failure modes
-
Unknown
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 allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.