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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Emotion 16

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 Class 2 Device Recall SOMATOM Emotion 16see related information
Date Initiated by FirmJune 04, 2015
Date PostedJune 27, 2015
Recall Status1 Terminated 3 on March 24, 2017
Recall NumberZ-1933-2015
Recall Event ID 71484
510(K)NumberK133424 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Code Information model numbers: 10165977, with serial numbers: 32310 32254 32322 32317 32303 32295 32327 32309 32319 32237 32326 32259 32323 32257 32298 32315 32268 32244 32252 32293 32349 32313 32334 32301 32339 32277 32292 32281 32273 32320 32324 32346 32270 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactCustomer Support
610-219-6300
Manufacturer Reason
for Recall		A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
FDA Determined
Cause 2		Device Design
ActionA safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.
Quantity in Commerce40 total
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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