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U.S. Department of Health and Human Services

Class 2 Device Recall Mammomat Revelation

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  Class 2 Device Recall Mammomat Revelation see related information
Date Initiated by Firm July 23, 2019
Create Date October 18, 2019
Recall Status1 Terminated 3 on May 06, 2020
Recall Number Z-0160-2020
Recall Event ID 83508
510(K)Number K173408  
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
Product Mammomat Revelation with software version VC10 and Biopsy Option

Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Code Information software version VC10 and Biopsy Option 
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		 An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
FDA Determined
Cause 2		 Software design
Action Siemens issued the customer notification on 7/23/19 via XP018/19/S. The Advisory Notice provides the problem, health risk and action to take: provided steps to the operator on how to easily release patient and proceed with exam. Siemens is developing a corrective action to resolve the issue, which will be released via Update Instruction XP021/19/S.
Quantity in Commerce 139 WW (33 US)
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 = MUE and Original Applicant = Siemens Medical Solutions, Inc.
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