The Recall Desk
HighFDA (Devices)·Z-0062-2020·Announced 2019-10-16

GE Healthcare Recalls AIR Technology Anterior Array MRI Coils

GE Healthcare is recalling 22 AIR Technology Anterior Array MRI coils because the outer seam may separate, exposing porous internal material that cannot be disinfected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (infection risk from non-disinfectable material) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 22 units of the AIR Technology Anterior Array, a receive-only RF coil designed for use with GE 3.0T MRI systems. The affected catalogue numbers are 5746694, 5746695, and 5746696.

The recall is due to a defect where the outer seam of the coil, closest to the system cable, may separate. This separation can expose the porous material internal to the coil. Because this internal porous material cannot be disinfected, there is a risk of user and/or patient contact with infectious agents.

The affected units were distributed worldwide, including in the United States (AZ, CA, MS, NY, WI, DE) and in France, Germany, Japan, the Netherlands, Spain, and Sweden. Users should stop using the affected coils and contact GE Healthcare for instructions on return or replacement.

The recalled product

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.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Coil
Hazard
Affected units
22

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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