FDA recall Z-0062-2020

GE Healthcare, LLC · Class II · device

Product

AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.

Reason for recall

The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.

Distribution

Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,

Key facts

Status
Terminated
Initiation date
2019-03-19
Report date
2019-10-16
Termination date
2020-03-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0062-2020