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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Sensis Vibe Systems

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  Class 2 Device Recall AXIOM Sensis Vibe Systems see related information
Date Initiated by Firm May 16, 2017
Create Date July 06, 2017
Recall Status1 Terminated 3 on August 22, 2018
Recall Number Z-2688-2017
Recall Event ID 77324
510(K)Number K020440  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Code Information Software Version VD10B
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Ms. Meredith Adams
610-448-6461
Manufacturer Reason
for Recall		 Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.
FDA Determined
Cause 2		 Software design
Action Siemens sent an Customer Safety Advisory Notice dated May 16, 2017, was mailed to all users on May 16, 2017. The letter informs customers of the software issue and potential impact. Siemens Medical Solutions will contact users to make arrangements to update the system with updated software to correct the issue. For further questions, please call (610) 448-6461.
Quantity in Commerce US: 13 units
Distribution US Distribution to the states of : IN, MI, IA
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 = DQK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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