Date Initiated by Firm |
October 19, 2016 |
Date Posted |
November 08, 2016 |
Recall Status1 |
Terminated 3 on March 13, 2017 |
Recall Number |
Z-0374-2017 |
Recall Event ID |
75509 |
510(K)Number |
K143416
|
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product |
SOMATOM Definition Flash system, x-ray, tomography, computed
|
Code Information |
Model Numbers: 8098027 10430603 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
Marlynne Galloway 610-448-6471
|
Manufacturer Reason for Recall |
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Siemens mailed a Customer Safety Advisory Notice to affected customers on October 19, 2016, to inform them about the hardware issue. The notice provided guidance on risk prevention and actions they are taking to develop a solution to correct the issue. For further questions, please call (610) 448-6471. |
Quantity in Commerce |
57 systems distributed in USA |
Distribution |
Nationwide Distribution |
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 = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
|