FDA Recall
Terminated
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Recall: Z-0033-2020
·
Initiated August 20, 2019
Recall
- Recall Number
- Z-0033-2020
- Event Number
- 83775
- Firm
- Quality Electrodynamics LLC
- FEI Number
- 3007350713
- Product Code
- MOS
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 20, 2019
- Terminated
- May 26, 2020
- Address
- 6655 Beta Dr, Ste 100, Mayfield Village, OH, 44143-2380
Description
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Reason
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
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.
Distribution
Worldwide distribution - US in the states: NC OUS: Germany
Quantity
5 units