International safety notice
During internal confirmation testing, due to a problem with the built-in software, air leakage occurred during operation at a set speed of 1 to 2mL/h and during KVO operation. It turned out that the foam alarm did not go off. We will carry out a voluntary recall of the product.
Japan / PMDA Recalls · JPN · May 21, 2024
Key facts
| Title | During internal confirmation testing, due to a problem with the built-in software, air leakage occurred during operation at a set speed of 1 to 2mL/h and during KVO operation. It turned out that the foam alarm did not go off. We will carry out a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose infusion pump Brand name: Top infusion pump TOP-i200 |
| Manufacturer | Top Co., Ltd. |
| Models | VT00539, VT00197, VT00558, VT00200, VT00703, VT00103, VT00286, VT00559, VT00545, VT00756, VT00527, VU01089 and 38 more |
| Date | May 21, 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