International safety notice
General names: (1), (3)~(7) Superconducting magnet type whole-body MR device, (2) MR combined せポジトロンCT device Sales name: (1) Optima MR450w (2) Signa PET/MR (3) Signa Pioneer (4) Signa Voyager (5) Discovery MR750w (6) Discovery MR750 (7) Magnetic resonance tomography device Optima MR360/Brivo MR355
Japan / PMDA Recalls · JPN · Jul 21, 2021
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General names: (1), (3)~(7) Superconducting magnet type whole-body MR device, (2) MR combined せポジトロンCT device Sales name: (1) Optima MR450w (2) Signa PET/MR (3) Signa Pioneer (4) Signa Voyager (5) Discovery MR750w (6) Discovery MR750 (7) Magnetic resonance tomography device Optima MR360/Brivo MR355 |
| Manufacturer | GE Healthcare Japan Co., Ltd. |
| Models | PC6166, PC5077, PC5070, PC6135, EM0101, PC6240, PC0921, PC6228, PC6226, PC0933, ZC0003, PC0929 and 646 more |
| Date | Jul 21, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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