International safety notice
General names: (1)-(13) Ultraconductive magnet-type whole-body MR device, (14) Nuclear medical diagnosis CT device Sales name: (1) Interra Achiba 1.5T (2) Gyroscan Interra 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)Philips 1.5T Superconducting magnetic resonance imaging device (8)Philips 3.0T Superconducting Magnetic Resonance Imaging Device (9) Full-body MR device Ingenia 1.5T CX (10) Full-body MR device Ingenia 3.0T CX (11)Philips Elition 3.0T (12)Philips Ambition 1.5T (13) Full-body MR device Multiva 1.5T (14)Ingenuity TF PET/MR equipment
Japan / PMDA Recalls · JPN · Feb 12, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General names: (1)-(13) Ultraconductive magnet-type whole-body MR device, (14) Nuclear medical diagnosis CT device Sales name: (1) Interra Achiba 1.5T (2) Gyroscan Interra 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)Philips 1.5T Superconducting magnetic resonance imaging device (8)Philips 3.0T Superconducting Magnetic Resonance Imaging Device (9) Full-body MR device Ingenia 1.5T CX (10) Full-body MR device Ingenia 3.0T CX (11)Philips Elition 3.0T (12)Philips Ambition 1.5T (13) Full-body MR device Multiva 1.5T (14)Ingenuity TF PET/MR equipment |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | 75049, 38223, 71825, 42262, 70454, 63043, 87136, 87175, 80608, 41357, 84535, 70053 and 994 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