International safety notice
Medical institutions in Japan have reported that the LCD screen does not display and alarms are activated. Upon investigation at the overseas manufacturer, it was determined that the IC chip on the LCD display board was defective. This has been confirmed, and similar events may occur with other serial numbers. We have decided to voluntarily recall the relevant serial numbers.
Japan / PMDA Recalls · JPN · Jan 20, 2022
Key facts
| Title | Medical institutions in Japan have reported that the LCD screen does not display and alarms are activated. Upon investigation at the overseas manufacturer, it was determined that the IC chip on the LCD display board was defective. This has been confirmed, and similar events may occur with other serial numbers. We have decided to voluntarily recall the relevant serial numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: enteral feeding infusion pump Brand name: Enteral feeding pump Amika |
| Manufacturer | Fresenius Kabi Japan Co., Ltd. |
| Models | 24669176, 24540169, 24541814, 24541781, 24541717, 24541797, 24573946, 24541807, 24541460, 24574054, 24541808, 24574014 and 815 more |
| Date | Jan 20, 2022 |
| 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