Data Foundry

Medical device recalls 2019

AIR Technology Anterior Array — Class II medical device recall Z-0062-2020

Terminated recall by GE Healthcare, LLC, reported 2019-10-16, distributed nationwide. The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal

Recall numberZ-0062-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2019-03-19
Classified2019-10-07
Reported by FDA2019-10-16
Terminated2020-03-30
DistributedNationwide (US)
Countries outside the USDE, ES, FR, JP, NL, SE
Quantity22 units
Serial numbers301, 303, 307, 311, 313, 315, 316, 319, 320, 321, 322, 323, 324, 325, 326, 328, 334, 335, 337, 338, 339, 340, 5746694, 5746695, 5746696
Model numbers5746694, 5746695, 5746696

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0062-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.