International safety notice
When setting the flow rate including the first decimal point, the value after the decimal point is not reflected, resulting in underdosing. It was discovered that there was a firmware defect in the control CPU. Therefore, the firmware of the devices subject to recall will be updated to firmware that has been addressed. We will carry out a voluntary recall. Please note that this issue only applies to devices equipped with a dedicated mode.
Japan / PMDA Recalls · JPN · Nov 10, 2023
Key facts
| Title | When setting the flow rate including the first decimal point, the value after the decimal point is not reflected, resulting in underdosing. It was discovered that there was a firmware defect in the control CPU. Therefore, the firmware of the devices subject to recall will be updated to firmware that has been addressed. We will carry out a voluntary recall. Please note that this issue only applies to devices equipped with a dedicated mode. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose infusion pump Brand name: CureSense infusion pump IP-100 |
| Manufacturer | Metek Co., Ltd. |
| Models | 21I0596D1, 21G0479D1, 20J0069D1, 20J0067D1, 21B0185D1, 21J0646D1, 21E0385D1, 20J0029D1, 22I0115S1, 21F0445D1, 21G0450D1, 22I0086S1 and 167 more |
| Date | Nov 10, 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