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.
FDA Recall Z-0062-2020 · Posted None
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMOS
Date Initiated2019-03-19
Date Terminated2020-03-30
Product Quantity22 units
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.
Firm Action
The firm hand delivered the notices beginning on 03/19/2019. The notices described the separation of the outer seam and requested that the consignee check each coil component for tears or damage, and to discontinue use of product if product is suspected of not being in good condition. The affected products will be replaced.
For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.