Date Initiated by Firm |
November 29, 2018 |
Create Date |
February 23, 2019 |
Recall Status1 |
Terminated 3 on May 07, 2020 |
Recall Number |
Z-0936-2019 |
Recall Event ID |
81959 |
510(K)Number |
K150493
|
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
Product |
Sensis Vibe System, Model Number 11007642, with software version VD10B. |
Code Information |
Serial Number 120019 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
Anastasia Sokolova 610-219-4834
|
Manufacturer Reason for Recall |
A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
|
FDA Determined Cause 2 |
Software design |
Action |
Urgent Medical Device Correction letters were sent to customers on 11/29/18. |
Quantity in Commerce |
1 |
Distribution |
The products were distributed to the following US states: NJ. |
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 Solutions, Inc.
|