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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Symbia T Series SPECT-CT System with a Pinhole Collimator		see related information
Date Posted February 23, 2007
Recall Number Z-0549-2007
Product Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717733
Code Information All systems with pinhole collimators and e.soft software versions 5.5 or earlier part number 08717733, serial numbers 01015, 01032, 01037, 01045, 01061, 01065, 01068, 01072, 01074, 01076, 01077
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates, Illinois 60195-2061
For Additional Information Contact Mr. Ron Nolte
800-767-2313
Reason for
Recall		 Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
Action Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.
Quantity in Commerce 11 units
Distribution Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.
 
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