International safety notice
The device provides CEDM (Contrast Enhanced Digital Mammography) with energy subtraction function It was approved by the pharmaceutical industry as possible. Therefore, energy subtraces that may give a false impression that they can be used in mammography examinations and induce their use in mammography examinations. We will conduct a voluntary recall to disable the action function.
Japan / PMDA Recalls · JPN · Apr 26, 2023
Key facts
| Title | The device provides CEDM (Contrast Enhanced Digital Mammography) with energy subtraction function It was approved by the pharmaceutical industry as possible. Therefore, energy subtraces that may give a false impression that they can be used in mammography examinations and induce their use in mammography examinations. We will conduct a voluntary recall to disable the action function. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Stationary digital breast X-ray diagnostic device Brand name: Digital breast X-ray diagnostic device FDR MS-3500 |
| Manufacturer | Fujifilm Co., Ltd. |
| Models | 06923520, 96722730, 36124949, 07123662, 76121058, 16223795, 77221623, 86722034 |
| Date | Apr 26, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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