International safety notice
For some serial numbers of OLYMPUS hysteroresectoscopes, water leakage tests are not performed during the manufacturing process. It has become clear that. We have decided to recall the affected products due to the possibility of damage occurring.
Japan / PMDA Recalls · JPN · May 16, 2024
Key facts
| Title | For some serial numbers of OLYMPUS hysteroresectoscopes, water leakage tests are not performed during the manufacturing process. It has become clear that. We have decided to recall the affected products due to the possibility of damage occurring. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Hard レゼクトスコープ Sales name: OLYMPUS Hysteroresectoscope |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | A4673A, 800532 |
| Date | May 16, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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