Date Initiated by Firm |
July 14, 2015 |
Date Posted |
August 05, 2015 |
Recall Status1 |
Terminated 3 on March 03, 2016 |
Recall Number |
Z-2337-2015 |
Recall Event ID |
71712 |
510(K)Number |
K123737
|
Product Classification |
System, tomography, computed, emission - Product Code KPS
|
Product |
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 |
Code Information |
SERIAL NUMBERS: 1041, 1042 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA Inc. 810 Innovation Dr Knoxville TN 37932-2562
|
For Additional Information Contact |
Service representatives 865-218-2000
|
Manufacturer Reason for Recall |
Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
|
FDA Determined Cause 2 |
Packaging change control |
Action |
The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015. |
Quantity in Commerce |
2 units |
Distribution |
Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland. |
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.
|