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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia S Series SPECT System

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 Class 2 Recall
Symbia S Series SPECT System
see related information
Date Posted November 23, 2011
Recall Status1 Terminated on October 16, 2012
Recall Number Z-0283-2012
Recall Event ID 60142
Premarket Notification
510(K) Number
K082506 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Code Information Symbia S Series systems, serial numbers 1236 and 1555, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12
Recalling Firm/
Manufacturer
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
847-304-7700
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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
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 2 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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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