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U.S. Department of Health and Human Services

Class 2 Device Recall Integrated Orbiter

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  Class 2 Device Recall Integrated Orbiter see related information
Date Initiated by Firm February 10, 2003
Date Posted March 06, 2003
Recall Status1 Terminated 3 on April 30, 2004
Recall Number Z-0617-03
Recall Event ID 25544
510(K)Number K850397  
Product Classification Camera, Scintillation (Gamma) - Product Code IYX
Product Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203
Code Information model 35-26-932, serial numbers 102, 1001/1217, 1169A; model 35-44-637, serial numbers 0101/0142, 120A
Recalling Firm/
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates IL 60195-5203
For Additional Information Contact Mr. Ron Nolte
Manufacturer Reason
for Recall
Unintended yoke rotational motion.
FDA Determined
Cause 2
Action Siemens sent Customer Advisory letters dated 2/10/03 to all Integrated Orbiter customers. The accounts were informed of the problem with unexpected camera movement in the opposite direction at the beginning of a SPECT study, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended camera rotation. The upgrade will be done free of charge.
Quantity in Commerce 256 units
Distribution Nationwide, United Arab Emirates, Argentina, Austria, Azerbaizan,Bangladesh, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Jordan, Japan, Korea, Norway, Pakistan, Romania, Switzerland, Tunisia, Venezuela and the Netherlands.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYX and Original Applicant = SIEMENS GAMMASONICS, INC.