Mayfield Village, OH, United States
Quality Electrodynamics LLC recalls
1 recall recorded since 2018, most recently on 20 August 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 August 2019
- Terminated
- 26 May 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0037-2020, Z-0033-2020, Z-0035-2020, Z-0031-2020, Z-0032-2020, Z-0034-2020, Z-0036-2020
- TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
- TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
- TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
- TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
- TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
- TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
- TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.