FDA Device recall Z-0128-2021
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution,…
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution,… by Ge Healthcare, citing potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0128-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-08 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Reason
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Identifiers
| code_info | Model: 5741000-23 and 5396469 |
|---|
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-0128-2021%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.