International safety notice
When measuring with the blood gas analyzer GASTAT-Pro using the sensor card of a specific lot, an equipment abnormality is detected. When we investigated the cause, we found that one of the sensor card components had a defective shape. It was determined that the problem was caused by the product being mixed in with the product, so we decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Apr 19, 2023
Key facts
| Title | When measuring with the blood gas analyzer GASTAT-Pro using the sensor card of a specific lot, an equipment abnormality is detected. When we investigated the cause, we found that one of the sensor card components had a defective shape. It was determined that the problem was caused by the product being mixed in with the product, so we decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose blood gas analyzer Brand name: Blood gas analyzer GASTAT-Pro |
| Manufacturer | Techno Medica Co., Ltd. |
| Models | 031723, 031623, 0187902, 021723, 030923, 033123, 0187901, 030323 |
| Date | Apr 19, 2023 |
| 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