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U.S. Department of Health and Human Services

Class 2 Device Recall e.cam Emission Computed Tomography Systems

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  Class 2 Device Recall e.cam Emission Computed Tomography Systems 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-1687-2012
Recall Event ID 61672
510(K)Number K952109  
Product Classification System, tomography, computed, emission - Product Code KPS
Product e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
Code Information Material number 4380213, serial numbers 1018 and 3020;  material number 4380221, serial numbers 0009, 1039, 1047, 1056, 1075, 1094, 1099, 1109, 1137, 1166, 1181 and 1190;  material number 5227397, serial number 1136;  material number 5242826, serial numbers 1005, 1024, 1060, 1065, 1070, 1071, 2046, 2050, 2053, 2059, 2070, 2071, 2111, 2114, 3005, 3007, 3019, 3060, 3092, 3098, 3122, 3124, 4024, 4027, 4035, 4039, 4042, 4044, 4060, 4067 and 4075;  material number 5977066, serial numbers 4092, 4165, 5030, 5048 and 5103;  material number 5977074, serial number 5031;  material number 5984005, serial number 7006;  material number 5989079, serial numbers 7538, 8003, 8009, 8031, 8046, 8097, 8527, 8546, 8652, 8665, 8694, 8730, 8744, 8764 and 08501/7823920;  Material number 5989087, serial numbers 7503, 8018, 8514 and 8542;  material number 5991109, serial numbers 5564, 5649,7009, 7017 and 7038;  material number 5991117, serial number 4005;  material number 5992099, serial numbers 5154, 5157 and 5502;  material number 7324143, serial number 0573;  material number 7760809, serial number 8502;  material number 7760932, serial numbers 8528, 8575 and 9024;  material number 7823920, serial number 8508;  material number 7823946, serial numbers 9088, 9092, 9112, 9128, 9161, 9171, 9203, 9210, 9237, 10036, 10038, 10095, 10097, 10137, 10161, 10239, 10306, 11017, 11040, 11071, 11145, 11186, 11195, 11226, 11291, 11298, 11411, 11419, 11477, 11496, 11505, 11653, 11660, 11762 and 11789; material number 7823953, serial numbers 9024, 11057 and 11139;  material number 7823979, serial number 9013;  material number 10151531, serial numbers 1021 and 1022; and  material number 10151532, serial numbers 1027, 1049, 1134, 1137, 1138, 1317, 1321, 1343 and 1345.
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 137 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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