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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia E Series SPECT System

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  Class 2 Device Recall Symbia E Series SPECT System see related information
Date Initiated by Firm May 15, 2012
Date Posted May 30, 2012
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-1686-2012
Recall Event ID 61672
510(K)Number K072567  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole-body scans, and SPECT studies.
Code Information Material number 10275879, serial numbers 1028, 1034, 1062, 1098, 1106, 1134, 1138, 1205 and 1283.
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		 Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys
FDA Determined
Cause 2		 Employee error
Action On May 15, 2012, Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated April 11, 2012 to all affected customers. The letters informed customers of the potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. Customers were informed that a Siemens Service Engineer will be inspecting the radial drive gear on their camera system to ensure it is functioning correctly. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at 800-888-7436.
Quantity in Commerce 9 units
Distribution Worldwide Distribution, US (Nationwide) and the countries of Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Republic of Korea, Mexico, Netherlands, Portugal, Spain, Taiwan and the United Kingdom.
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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