Recall Z-0033-2020
Quality Electrodynamics LLC · initiated August 20, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Codes / lots: Serial # 1308 1309 1310 1311 1313
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 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.
Details
- Recall number
- Z-0033-2020
- Initiated
- August 20, 2019
- Terminated
- May 26, 2020
- Product code
- MOS – Coil, Magnetic Resonance, Specialty
- Quantity
- 5 units
- Distribution
- Worldwide distribution - US in the states: NC OUS: Germany
- Recalling firm
- Quality Electrodynamics LLC, Mayfield Village, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0031-2020 Class II | TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | 08/20/2019Terminated |
| Z-0032-2020 Class II | TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | 08/20/2019Terminated |
| Z-0034-2020 Class II | TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | 08/20/2019Terminated |
| Z-0035-2020 Class II | TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | 08/20/2019Terminated |
| Z-0036-2020 Class II | TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | 08/20/2019Terminated |
| Z-0037-2020 Class II | TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | 08/20/2019Terminated |