FDA recall Z-0033-2020

Quality Electrodynamics LLC · Class II · device

Product

TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464

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-0033-2020