Z-0031-2020 Class II Terminated

Recalled by Quality Electrodynamics LLC — Mayfield Village, OH

FDA device recall Z-0031-2020 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: 2 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
2 units

Product Description

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

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 # 1459 1460