International safety notice
General name: (1)-(12) Superconducting magnet type whole-body MR device Sales name: (1) Gyro Scan Intera 1.5T (2) Intera Achiever 1.5T (3) Achieva 3.0T (4) Achiever 3.0T TX (5) Whole-body MR device Intera/Achieva 1.5T (6) Whole body MR device Achieva 3.0T (7)Philips 1.5T superconducting magnetic resonance imaging device (8)Philips 3.0T superconducting magnetic resonance imaging device (9) Whole body MR device Ingenia 1.5T CX (10) Whole-body MR device Ingenia 3.0T CX (11)Philips Elition 3.0T (12)Philips Ambition 1.5T
Japan / PMDA Recalls · JPN · Jan 19, 2022
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: (1)-(12) Superconducting magnet type whole-body MR device Sales name: (1) Gyro Scan Intera 1.5T (2) Intera Achiever 1.5T (3) Achieva 3.0T (4) Achiever 3.0T TX (5) Whole-body MR device Intera/Achieva 1.5T (6) Whole body MR device Achieva 3.0T (7)Philips 1.5T superconducting magnetic resonance imaging device (8)Philips 3.0T superconducting magnetic resonance imaging device (9) Whole body MR device Ingenia 1.5T CX (10) Whole-body MR device Ingenia 3.0T CX (11)Philips Elition 3.0T (12)Philips Ambition 1.5T |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | 78145, 71878, 41362, 77071, 46017, 71880, 77100, 10498, 77155, 71589, 42424, 78100 and 717 more |
| Date | Jan 19, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 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