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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia S Series SPECT System with a Pinhole Collimator

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 Class 2 Recall
Symbia S Series SPECT System with a Pinhole Collimator
see related information
Date Posted February 23, 2007
Recall Status1 Terminated on November 30, 2007
Recall Number Z-0548-2007
Recall Event ID 37231
Premarket Notification
510(K) Number
K041166 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Symbia S Series SPECT (Single-Photon Emission 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 08717741
Code Information All systems with pinhole collimators and e.soft software versions 5.5 or earlier: part number 08717741, serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032, 01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052
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
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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 16 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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