Recall Z-0036-2020 ยท MOS Coil, Magnetic Resonance, Specialty
Quality Electrodynamics LLC
TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
| Date | Aug 20, 2019 |
| Status | Terminated |
| Reason | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Root 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 | 36 units |
| Distribution | Worldwide distribution - US in the states: NC OUS: Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T Quality Electrodynamics, Sep 25, 2008 |