Date Initiated by Firm |
July 27, 2012 |
Date Posted |
September 06, 2012 |
Recall Status1 |
Terminated 3 on February 19, 2013 |
Recall Number |
Z-2314-2012 |
Recall Event ID |
62949 |
510(K)Number |
K082636
|
Product Classification |
Coil, magnetic resonance, specialty - Product Code MOS
|
Product |
TxRx Knee 15 Coil 3T.
For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician. |
Code Information |
QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022. |
Recalling Firm/ Manufacturer |
Quality Electrodynamics LLC 700 Beta Dr Ste 100 Mayfield Village OH 44143-2378
|
For Additional Information Contact |
Christie L. Zydyk, MBA 440-484-2228
|
Manufacturer Reason for Recall |
On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.
|
FDA Determined Cause 2 |
Error in labeling |
Action |
Since all of the devices were located at various Siemens distribution locations, all communications were internal to Siemens concerning bringing the coils from one warehouse to another. |
Quantity in Commerce |
17 units |
Distribution |
Worldwide distribution: USA (nationwide): Tennessee only and country of: 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 = MOS and Original Applicant = QUALITY ELECTRODYNAMICS
|