Z-0035-2020 Class II Terminated
FDA device recall Z-0035-2020 was initiated by Quality Electrodynamics LLC on August 20, 2019 and is designated Class II. Reason for recall: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. The recall status is terminated (terminated May 26, 2020). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- August 20, 2019
- Termination Date
- May 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
Reason for Recall
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Distribution Pattern
Worldwide distribution - US in the states: NC OUS: Germany
Code Information
Serial # 1571 1572 1573 1574 1575