International safety notice
General name: Ultra-conductive magnet-type full-body MR device Sales name: 1) Gyroscan Interra 1.5T 2) Interra Achiba 1.5T 3) Achiba 3.0T 4) Achiba 3.0T TX 5) Full-body MR device Intera/Achieva 1.5T 6) Full-body MR device Achieva 3.0T 7) Full-body MR device Ingenia 1.5T CX
Japan / PMDA Recalls · JPN · Feb 12, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: Ultra-conductive magnet-type full-body MR device Sales name: 1) Gyroscan Interra 1.5T 2) Interra Achiba 1.5T 3) Achiba 3.0T 4) Achiba 3.0T TX 5) Full-body MR device Intera/Achieva 1.5T 6) Full-body MR device Achieva 3.0T 7) Full-body MR device Ingenia 1.5T CX |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | 32794, 20319, 21413, 21222, 78021, 21129, 21579, 34135, 10544, 78019, 32713, 22175 and 472 more |
| Date | Feb 12, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1,000+ Matching device models in FDA data
- 1,000+ 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