International safety notice
In response to complaints that the casing (battery pack) of this product opens overseas, the overseas manufacturer conducted a detailed investigation. As a result, similar defects were confirmed in some lots, and a voluntary recall was implemented for specific lots of this product. I received a notification that. For this reason, we have decided to implement a voluntary recall of the affected lots of products in Japan.
Japan / PMDA Recalls · JPN · Mar 28, 2024
Key facts
| Title | In response to complaints that the casing (battery pack) of this product opens overseas, the overseas manufacturer conducted a detailed investigation. As a result, similar defects were confirmed in some lots, and a voluntary recall was implemented for specific lots of this product. I received a notification that. For this reason, we have decided to implement a voluntary recall of the affected lots of products in Japan. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose light source Sales name: Surgical light KLARO |
| Manufacturer | AS ONE Co., Ltd. |
| Models | 2112AI, 8-409-01 |
| Date | Mar 28, 2024 |
| 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