International safety notice
In the United States, there was one incident where the C-arm of the device did not stop at the specified position and moved to the bottom. Ta. Therefore, we have decided to conduct an inspection and, if there is a possibility of the problem, replace the part that causes it.
Japan / PMDA Recalls · JPN · Feb 9, 2023
Key facts
| Title | In the United States, there was one incident where the C-arm of the device did not stop at the specified position and moved to the bottom. Ta. Therefore, we have decided to conduct an inspection and, if there is a possibility of the problem, replace the part that causes it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Stationary digital breast X-ray diagnostic device Brand name: Digital mammography system Selenia Dimensions |
| Manufacturer | Hologic Japan Co., Ltd. |
| Models | SDM181500123, SDM181700192, 81002177876, SDM131500137 |
| Date | Feb 9, 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