International safety notice
Common name: Stationary digital cardiovascular X-ray fluoroscopic diagnostic equipment Brand name: (1) X-ray cardiovascular diagnostic system Alphenix INFX-8000C (2) X-ray cardiovascular diagnostic system Alphenix INFX-8000F (3) X-ray cardiovascular diagnostic system Alphenix INFX-8000H (4) X-ray cardiovascular diagnostic system Alphenix INFX-8000V (5) Floor-standing C-arm type holding device CAS-810A (6) Ceiling traveling C-arm type holding device CAS-830A
Japan / PMDA Recalls · JPN · May 21, 2024
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common name: Stationary digital cardiovascular X-ray fluoroscopic diagnostic equipment Brand name: (1) X-ray cardiovascular diagnostic system Alphenix INFX-8000C (2) X-ray cardiovascular diagnostic system Alphenix INFX-8000F (3) X-ray cardiovascular diagnostic system Alphenix INFX-8000H (4) X-ray cardiovascular diagnostic system Alphenix INFX-8000V (5) Floor-standing C-arm type holding device CAS-810A (6) Ceiling traveling C-arm type holding device CAS-830A |
| Manufacturer | Canon Medical Systems Inc. |
| Models | JPA12Z2005, TFA23X2002, N7C1682032, HED2212010, NEC1792008, HXC2052004, JNA1242001, J3C08Y2015, N7A1422002, JEC1182034, N9C1722031, H7C2022016 and 1055 more |
| Date | May 21, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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