Date Initiated by Firm |
February 01, 2018 |
Date Posted |
March 30, 2018 |
Recall Status1 |
Terminated 3 on May 01, 2020 |
Recall Number |
Z-2472-2018 |
Recall Event ID |
79665 |
510(K)Number |
K023687
|
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product |
SOMATOM Emotion 6 (Model 10165888) |
Code Information |
Serial No. 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 |
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 |
A potential risk of unnecessary radiation exposure due to a software issue
|
FDA Determined Cause 2 |
Software design |
Action |
Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts. |
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 = JAK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
|