FDA Device

TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460

Hazard

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

What You Should Do

Remedy

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.

Products

TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Brand
Quality Electrodynamics LLC
UPC
Serial # 1459 1460

Units Affected

2 units