Date Initiated by Firm |
November 13, 2014 |
Date Posted |
December 16, 2014 |
Recall Status1 |
Terminated 3 on July 09, 2015 |
Recall Number |
Z-0807-2015 |
Recall Event ID |
69897 |
510(K)Number |
K123737
|
Product Classification |
System, tomography, computed, emission - Product Code KPS
|
Product |
Biograph mCT Flow Edge-4R, System Material Number 10528955.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. |
Code Information |
Serial Numbers: 11002, 11005, 11006, 11008 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA Inc. 810 Innovation Dr Knoxville TN 37932-2562
|
For Additional Information Contact |
Jeffrey Bell 865-218-2000
|
Manufacturer Reason for Recall |
Possibility for system display freeze during CT interventional procedures.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm initiated their recall by certified mail on 11/13/2014. |
Quantity in Commerce |
4 units |
Distribution |
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany. |
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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
|