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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Emotion 16 and Spirit Computed Tomography Systems

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 Class 2 Recall
Siemens Emotion 16 and Spirit Computed Tomography Systems
see related information
Date Posted June 04, 2014
Recall Status1 Open
Recall Number Z-1721-2014
Recall Event ID 67967
Premarket Notification
510(K) Number
K050297 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Siemens SOMATOM Emotion 16 and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Code Information Material numbers: 10165977, 10045692 with serial numbers: 32187 31158 31215 31222 31313 31354 32118 32120 32123 32125 32126 32127 32129 32139 32141 32156 32159
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Siemens sent a Customer Safety Advisory Notice/ Field Safety Notice letter dated March 21, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that the system modification would be implemented by Siemens service specialists in April 2014 to correct the problem.
Quantity in Commerce 17
Distribution US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.
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 = JAK and Original Applicant = SIEMENS MEDICAL SOLUTION, INC. USA
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