FDA recall Z-0031-2020

Quality Electrodynamics LLC · Class II · device

Product

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

Worldwide distribution - US in the states: NC OUS: Germany

Key facts

Status: Terminated
Initiation date: 2019-08-20
Report date: 2019-10-09
Termination date: 2020-05-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mayfield Village, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0031-2020