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U.S. Department of Health and Human Services

Class 2 Device Recall TxRx 15CH Knee Coil 1.5T

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  Class 2 Device Recall TxRx 15CH Knee Coil 1.5T see related information
Date Initiated by Firm August 20, 2019
Create Date October 03, 2019
Recall Status1 Terminated 3 on May 26, 2020
Recall Number Z-0032-2020
Recall Event ID 83775
510(K)Number K082636  
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
Product TxRx 15CH Knee Coil 1.5T
QED part number:Q7000016
Siemens Model # 10185453
Code Information Serial # 1471 2106 1991  
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 3 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
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