International safety notice
An incident occurred where the nut that secures this device and the adda stand, which is an optional item for this device, fell off. An investigation into the cause revealed that a defective product (nut falling off) was mixed into the target lot of products manufactured under specific conditions. We are voluntarily recalling the product as we have discovered that it may have been.
Japan / PMDA Recalls · JPN · May 11, 2023
Key facts
| Title | An incident occurred where the nut that secures this device and the adda stand, which is an optional item for this device, fell off. An investigation into the cause revealed that a defective product (nut falling off) was mixed into the target lot of products manufactured under specific conditions. We are voluntarily recalling the product as we have discovered that it may have been. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Device for removing blood cells Sales name: Adamonitor SC |
| Manufacturer | Otsuka Electronics Co., Ltd. |
| Models | 570001, 570047 |
| Date | May 11, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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