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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SOMATOM go.Top

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  Class 2 Device Recall Siemens SOMATOM go.Top see related information
Date Initiated by Firm September 24, 2019
Create Date November 21, 2019
Recall Status1 Open3, Classified
Recall Number Z-0265-2020
Recall Event ID 83883
510(K)Number K173632  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM go.Top, Models 11061640 & 11061648-
a Computer tomography x-ray system
Code Information software syngo CT VA20A_SP2 and active Guide&GO license
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
FDA Determined
Cause 2		 Software design
Action Siemens issued a Customer Safety Advisory Notice to customers via CT072/19 on 9/24/2019. The letter identifies the problem, health risk and action to take: To avoid this issue, please refrain from using the i-Sequence scan mode in combination with the 3x3 mm collimation until this issue has been solved. Please use the i-Sequence with the 3x5 mm collimation instead, as here the correct dose information will be shown. This issue will be resolved with an improved software version syngo CT VA20A_SP2b. The software update will be released, free of charge, with the update CT073/19/S for all affected systems. The software update release is planned for Q3/2019. All future service packs will contain the update as well. Questions: contact service organization at 1-800-888-7436.
Quantity in Commerce 14 US
Distribution US in the states of: GA, IN, MO, MS, NJ, OH, PA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Siemens Medical Solutions USA, Inc.
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