TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
This recall has been terminated (originally issued August 20, 2019).
- Company
- Quality Electrodynamics Llc
- Recall Initiated
- August 20, 2019
- Terminated
- May 26, 2020
- Recall Number
- Z-0033-2020
- Quantity
- 5 units
- Firm Location
- Mayfield Village, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Distribution
Worldwide distribution - US in the states: NC OUS: Germany
Lot / Code Info
Serial # 1308 1309 1310 1311 1313
Root Cause
Nonconforming Material/Component
Action Taken
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.