FDA Device recall Z-0062-2020
AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.…
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II 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.… by Ge Healthcare, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0062-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-19 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalogue # UDI # Mfg. Lot or Serial # 5746694 0100840682138611111812132100339 339 5746694 01008406821386111118091221…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 010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0062-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.