International safety notice
Common name: Program for general-purpose diagnostic imaging equipment workstations Sales name: (1)eZIS Neuro (2)3DSRT neuro (3) smartMIBG heart (4) Born Navi BSI (5) Cardio report (6) Amygo neuro
Japan / PMDA Recalls · JPN · Jun 22, 2022
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common name: Program for general-purpose diagnostic imaging equipment workstations Sales name: (1)eZIS Neuro (2)3DSRT neuro (3) smartMIBG heart (4) Born Navi BSI (5) Cardio report (6) Amygo neuro |
| Manufacturer | PDR Pharma Co., Ltd. |
| Models | V1.0.0, A1701, V3.1.0, V1.1.0, C1702, V1.1.2, V1.0.6, V1.0.3, V2.1.7, F1701, V1.1.1, C1501 and 15 more |
| Date | Jun 22, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 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