FDA recall Z-0131-2021

Product

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

Key facts

Status

Terminated

Initiation date

2020-09-08

Report date

2020-10-28

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0131-2021