International safety notice
General names: (1)-(10) Superconducting magnet type whole body MR device, (11) MR combination type positron CT device Brand name: (1) Signa nuclear magnetic resonance computed tomography system (2) Optima MR450w (3) Signa EXCITE HDx 1.5T (4) Signa EXCITE HDx3.0T (5) Signa Pioneer (6) Signa Prime (7) Signa Voyager (8) Discovery MR750 (9) Discovery MR750w (10) Magnetic resonance tomography device Optima MR360/Brivo MR355 (11) Signa PET/MR
Japan / PMDA Recalls · JPN · Jun 28, 2024
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General names: (1)-(10) Superconducting magnet type whole body MR device, (11) MR combination type positron CT device Brand name: (1) Signa nuclear magnetic resonance computed tomography system (2) Optima MR450w (3) Signa EXCITE HDx 1.5T (4) Signa EXCITE HDx3.0T (5) Signa Pioneer (6) Signa Prime (7) Signa Voyager (8) Discovery MR750 (9) Discovery MR750w (10) Magnetic resonance tomography device Optima MR360/Brivo MR355 (11) Signa PET/MR |
| Manufacturer | GE Healthcare Japan Co., Ltd. |
| Models | MR00001, YM1816, YM1770, EM0126, YM3814, EM0601, MR00142, MR00076, YM1461, ZC0014, PC6267, EM0281 and 647 more |
| Date | Jun 28, 2024 |
| 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