International safety notice
General names: (1)~(5) Ultraconductive magnet-type whole-body MR device, (6) MR combination CT device Sales name: (1) Optima MR450w (2)Signa Pioneer (3)Signa Voyager (4) Discovery MR750 (5) Discovery MR750w (6)Signa PET/MR
Japan / PMDA Recalls · JPN · Jul 24, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General names: (1)~(5) Ultraconductive magnet-type whole-body MR device, (6) MR combination CT device Sales name: (1) Optima MR450w (2)Signa Pioneer (3)Signa Voyager (4) Discovery MR750 (5) Discovery MR750w (6)Signa PET/MR |
| Manufacturer | GE Healthcare Japan Co., Ltd. |
| Models | EM0292, EM0113, EM0289, EM0006, MR00175, EM0109, EM0608, EM0213, EM0250, EM0153, EM0129, EM0210 and 307 more |
| Date | Jul 24, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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