International safety notice
The misalignment between the collimator's light field and the X-ray field may not meet the JIS standard (JIS Z 4751-2-54:2017). As we understand this, we will voluntarily recall the product.
Japan / PMDA Recalls · JPN · Apr 26, 2021
Key facts
| Title | The misalignment between the collimator's light field and the X-ray field may not meet the JIS standard (JIS Z 4751-2-54:2017). As we understand this, we will voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Portable analog general-purpose integrated X-ray diagnostic equipment Brand name: Portable X-ray imaging device XD2000 |
| Manufacturer | Fujifilm Co., Ltd. |
| Models | XDRH-0150, XDRH-0106, XDRH-0159, XDRH-0028, XDRH-0158, XDRH-0161, XDRH-0151, XDRH-0025, XDRH-0045, XDRH-0005, XDRH-0105, XDRH-0021 and 85 more |
| Date | Apr 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