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
|
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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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