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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Spirit(Model 10045692 )

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  Class 2 Device Recall SOMATOM Spirit(Model 10045692 ) see related information
Date Initiated by Firm February 01, 2018
Date Posted March 30, 2018
Recall Status1 Terminated 3 on May 01, 2020
Recall Number Z-2478-2018
Recall Event ID 79665
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Spirit(Model 10045692 )
Code Information Serial No. 31621 31245 79670 31092 31313 31611  
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Marlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		 A potential risk of unnecessary radiation exposure due to a software issue
FDA Determined
Cause 2		 Software design
Action Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
Distribution Nationwide
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.
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