International safety notice
General names: (1)~(11) Superconducting magnet type MR device for whole body, (12) Superconducting magnet type MR device for head and limbs, (13) MR combination type Positron CT device Sales name: (1) Optima MR450w (2) Signa Pioneer (3) Signa Voyager (4) Discovery MR750w (5) Magnetic resonance tomography device Optima MR360/Brivo MR355 (6) SignaContour magnetic resonance tomography device (7) Signa EXCITE HDx 1.5T (8) Signa EXCITE HDx 3.0T (9) Signa Echo Speed (10) Signa nuclear magnetic resonance computed tomography system (11) Discovery MR750 (12) Optima MR 430s 1.5T (13) Signa PET/MR
Japan / PMDA Recalls · JPN · Jul 8, 2022
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General names: (1)~(11) Superconducting magnet type MR device for whole body, (12) Superconducting magnet type MR device for head and limbs, (13) MR combination type Positron CT device Sales name: (1) Optima MR450w (2) Signa Pioneer (3) Signa Voyager (4) Discovery MR750w (5) Magnetic resonance tomography device Optima MR360/Brivo MR355 (6) SignaContour magnetic resonance tomography device (7) Signa EXCITE HDx 1.5T (8) Signa EXCITE HDx 3.0T (9) Signa Echo Speed (10) Signa nuclear magnetic resonance computed tomography system (11) Discovery MR750 (12) Optima MR 430s 1.5T (13) Signa PET/MR |
| Manufacturer | GE Healthcare Japan Co., Ltd. |
| Models | PC0849, PC6065, YM1755, PC0609, PC6154, PC6058, PC0408, EM0607, PC6244, YM3855, EX0132, YM1774 and 1426 more |
| Date | Jul 8, 2022 |
| 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