International safety notice
Depending on the type of X-ray device and imaging table used in combination, lower bone mineral measurements of the femur may be output than originally intended. It has been found that this may lead to misdiagnosis. We have decided to voluntarily recall Function A.
Japan / PMDA Recalls · JPN · May 26, 2021
Key facts
| Title | Depending on the type of X-ray device and imaging table used in combination, lower bone mineral measurements of the femur may be output than originally intended. It has been found that this may lead to misdiagnosis. We have decided to voluntarily recall Function A. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: X-ray flat detector output reading type digital radiograph Sales name: Digital Radiography DR-ID 1500 |
| Manufacturer | Fujifilm Co., Ltd. |
| Models | 96220074, 86920034, 86920030, 96220068, 86920023, 86920049, 86920042, 86920046, 96220070, 96220066, 96220072, 96320083 and 1 more |
| Date | May 26, 2021 |
| 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