Class 2 Device Recall TxRx 15CH Knee Coil 3T

• Date Initiated by Firm: August 20, 2019
• Create Date: October 03, 2019
• Recall Status: Terminated on May 26, 2020
• Recall Number: Z-0035-2020
• Recall Event ID: 83775
• 510(K)Number: K082636
• Product Classification: Coil, magnetic resonance, specialty - Product Code MOS
• Product: TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
• Code Information: Serial # 1571 1572 1573 1574 1575
• 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: 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: 5 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