Date Initiated by Firm |
August 20, 2019 |
Create Date |
October 03, 2019 |
Recall Status1 |
Terminated 3 on May 26, 2020 |
Recall Number |
Z-0036-2020 |
Recall Event ID |
83775 |
510(K)Number |
K082636
|
Product Classification |
Coil, magnetic resonance, specialty - Product Code MOS
|
Product |
TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 |
Code Information |
Serial # 1694 1841 1887 1933 1998 3195 3291 3292 3293 3294 3298 3299 3300 3301 3302 3303 3304 3305 3306 3307 3308 3309 3310 3311 3312 3313 3314 3315 3316 3317 3318 ¿1137 ¿1361 ¿1378 ¿1628 ¿2447 |
Recalling Firm/ Manufacturer |
Quality Electrodynamics LLC 6655 Beta Dr Ste 100 Mayfield Village OH 44143-2380
|
For Additional Information Contact |
Timothy Stuthers 440-484-2344
|
Manufacturer Reason for Recall |
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm sent a notification letter to their customers who that have received the affected device. Customers were instructed to. 1. Immediately examine your inventory and quarantine product subject to recall. 2. if you have further distributed this product to MRI end users, please
identify your affected customers and notify them.
3. Please ensure they understand to stop use of the coil for scanning and to notify you immediately. |
Quantity in Commerce |
36 units |
Distribution |
Worldwide distribution - US in the states: NC
OUS: 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
|