FDA-Device2019-10-16Class II
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.
GE Healthcare, LLC
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,
Affected count
22 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0062-2020Don't want to check this manually?
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