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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Definition AS

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 Class 2 Device Recall SOMATOM Definition ASsee related information
Date Initiated by FirmMarch 22, 2016
Date PostedApril 08, 2016
Recall Status1 Terminated 3 on August 07, 2017
Recall NumberZ-1350-2016
Recall Event ID 73639
510(K)NumberK143400 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
Code Information Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMarlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation
FDA Determined
Cause 2		Other
ActionSiemens sent an "Informational Only" notice to customers on 03/22/2016 informing them to be aware that the front cover on some Siemens CT systems was not properly welded. The letter was only to notify customers that the issue is being addressed with the completion of a service visit. In addition, Siemen plans to replace each cover and hand delivered each notification to customers at the time the service is performed.
Quantity in Commerce1 CT system
DistributionDistributed to: Cincinnati, OH.
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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