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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia T16 System

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 Class 2 Recall
Symbia T16 System
see related information
Date Posted October 27, 2008
Recall Status1 Terminated on December 09, 2009
Recall Number Z-0190-2009
Recall Event ID 49456
Premarket Notification
510(K) Number
K041166 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to perform CT scans and nuclear imaging studies with the same instrument, obtaining attenuation corrected images and providing registration of anatomical and physiological images within the patient's anatomy. The Symbia T6 System is used for advanced oncology, neurology and cardiology applications.
Code Information System part number 10275010, serial numbers 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, and 1010; CT Subassembly 10165633, serial numbers 69003 through 69012
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates, Illinois 60195-2061
For Additional Information Contact Mr. Ron Nolte
847-304-7700
Manufacturer Reason
for Recall
The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 9/29/08 to all users of the Symbia T6 and Symbia T16 Systems. The accounts were informed of the potential risk that the protective plastic cap over the CT gantry power switch could come loose, causing an electrical hazard. The customers were advised to avoid contact with the gantry power switch until the protective plastic cap has been replaced, and to leave the power switch on at the line connection box and cycle the CT gantry on and off by toggling the CT gantry circuit breaker within the circuit box. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective update to their Symbia system free of charge. The accounts were requested to complete and return the enclosed mandatory fax-back form to 1-865-218-3019, acknowledging the receipt and understanding of the 9/29/08 letter and providing their Symbia System model number and serial number. Contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 for assistance.
Quantity in Commerce 10 units
Distribution Nationwide to the District of Columbia, Florida, Georgia, Illinois, Indiana, Missouri, Ohio, and Texas, and internationally to Australia, Brazil, Canada, Great Britain, India, Italy, Japan, Norway and Switzerland.
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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