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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 Device Recall Symbia S Series SPECT System see related information
Date Initiated by Firm April 22, 2009
Date Posted August 04, 2009
Recall Status1 Terminated 3 on June 21, 2010
Recall Number Z-1676-2009
Recall Event ID 52091
510(K)Number K041166  
Product Classification Emission Computed Tomography System - Product Code KPS
Product Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061

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 part 8717741, serial numbers 1326, 1315, 1324, 1330, 1310, 1325, 1336, 1307, 1317, 1331, 1299, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1311, 1312, 1313, 1314, 1316, 1318, 1319, 1320, 1322, 1323, 1327, 1328, 1329, 1332, 1334, 1335, and 1337. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60195-2061
For Additional Information Contact Mr. Ron Nolte
847-304-7700
Manufacturer Reason
for Recall		 The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.
FDA Determined
Cause 2		 Finished device change control
Action Siemens sent Urgent Field Correction Recall letters dated 4/22/09 to the affected users of the Symbia S and Symbia T Systems. The accounts were informed of the potential faulty pinion gear which could crack and cause the gantry to spin freely, damaging the system and potentially injuring a patient during a scan. The customers were advised to stop using the system if they hear any abnormal grinding noise from the gantry. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a replacement of the pinion gear free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.
Quantity in Commerce 37 units
Distribution Worldwide Distribution -- USA, Australia, Austria, Brazil, Bulgaria, Canada, China, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Russia, Spain, Taiwan, and Turkey.
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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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