International safety notice
The "Atom Infusion Pump AS-800" manufactured and sold by our company will be JIS T 060 from March 2021 production. 1-2-24: 2018 Manufactured in compliance with "Individual requirements for basic safety and basic performance of infusion pumps and infusion controllers" products (products with a "power outage alarm" function that activates when both the battery and AC power are lost) Unfortunately, it has been discovered that the product was being produced and supplied using the old specifications. Therefore, we will be recalling products manufactured after March 2021.
Japan / PMDA Recalls · JPN · Jan 18, 2022
Key facts
| Title | The "Atom Infusion Pump AS-800" manufactured and sold by our company will be JIS T 060 from March 2021 production. 1-2-24: 2018 Manufactured in compliance with "Individual requirements for basic safety and basic performance of infusion pumps and infusion controllers" products (products with a "power outage alarm" function that activates when both the battery and AC power are lost) Unfortunately, it has been discovered that the product was being produced and supplied using the old specifications. Therefore, we will be recalling products manufactured after March 2021. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose infusion pump Brand name: Atom infusion pump AS-800 |
| Manufacturer | Atom Medical Co., Ltd. |
| Models | 0900346, 210900200, 211100385, 210900342, 210900198, 210900345, 210900202, 211100383, 210900343, 210900340, 210900196, 211000842 and 25 more |
| Date | Jan 18, 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