Z-0062-2020Class II

AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF...

Name: Z-0062-2020 AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF...
Creator: GE Healthcare, LLC
Published: 2019-03-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-03-19 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of 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 on 2019-03-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0062-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-19
Posted: 2019-10-07
Terminated: 2020-03-30
Recalling firm: GE Healthcare
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.
Product code: MOS Coil, Magnetic Resonance, Specialty
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.
Root cause tag: design
FDA root cause: Device Design
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
Quantity in commerce: 22 units
Distribution: Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,
Product codes and lots: Catalogue # UDI # Mfg. Lot or Serial # 5746694 0100840682138611111812132100339 339 5746694 0100840682138611111809122100324 324 5746694 0100840682138611111805312100311 311 5746694 0100840682138611111901022100340 340 5746694 0100840682138611111811302100334 334 5746694 0100840682138611111808302100323 323 5746694 0100840682138611111809132100325 325 5746694 0100840682138611111809192100326 326 5746694 0100840682138611111801292100303 303 5746694 0100840682138611111801232100301 301 5746694 0100840682138611111808152100319 319 5746694 0100840682138611111808272100320 320 5746694 0100840682138611111812042100335 335 5746694 0100840682138611111806072100313 313 5746694 0100840682138611111807182100315 315 5746694 0100840682138611111802122100307 307 5746694 0100840682138611111811092100328 328 5746694 0100840682138611111812072100337 337 5746694 0100840682138611111807232100316 316 5746695 0100840682138611111808282100321 321 5746695 0100840682138611111808292100322 322 5746696 0100840682138611111812132100338 338

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0062-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0062-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07

Product code MOS

K172695Class IIAIR Anterior Array, AIR Posterior ArrayGe Healthcare Coils (Usa Instruments, Inc.) / cleared 2017-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)