International safety notice
General name: Ultra-conductive magnet-type full-body MR device Sales name: Magnetic resonance tomography device Optima MR360/Brivo MR355
Japan / PMDA Recalls · JPN · Feb 28, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: Ultra-conductive magnet-type full-body MR device Sales name: Magnetic resonance tomography device Optima MR360/Brivo MR355 |
| Manufacturer | GE Healthcare Japan Co., Ltd. |
| Models | PC6152, PC0612, MR00192, PC6247, PC6294, PC6178, MR00179, PC6289, MR00098, PC0836, PC6252, MR00195 and 225 more |
| Date | Feb 28, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1