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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Perspective 16 (Model 10891666)

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  Class 2 Device Recall SOMATOM Perspective 16 (Model 10891666) 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-2475-2018
Recall Event ID 79665
510(K)Number K113287  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Perspective 16 (Model 10891666)
Code Information Serial No. 87559 87579 87532 87539 87563 87565 87560 87555 87556 87553 87554 87526 87567 87561 87589 87569 87535 87525 87548 87541 87558 87533 87537 87522 87542 87534 87549 87546 87584 87574 87552 87600 87577 87571 87528 87540 87594 87544 
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.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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