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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia T Series SPECTCT System

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 Class 2 Recall
Symbia T Series SPECTCT System
see related information
Date Posted November 23, 2011
Recall Status1 Terminated on October 16, 2012
Recall Number Z-0284-2012
Recall Event ID 60142
Premarket Notification
510(K) Number
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
Code Information Symbia T Series systems, serial numbers 12316, 1236 and 1013, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12
Recalling Firm/
Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates, Illinois 60195-2061
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Ron Nolte
Manufacturer Reason
for Recall
Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems.
FDA Determined
Cause 2
Action Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436.
Quantity in Commerce 3 units
Distribution Florida, Illinois and Texas
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 = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.