International safety notice
The manufacturer has informed us that due to a manufacturing issue, the device has a lower value than the value set on the vaporizer dial. It turned out that an anesthetic of the concentration could be supplied. For this reason, we provide information to our customers based on the manufacturer's information, and we also inspect the vaporizer and, if a problem is identified, In the same way, we will carry out recovery work to replace the vaporizer.
Japan / PMDA Recalls · JPN · Jan 10, 2025
Key facts
| Title | The manufacturer has informed us that due to a manufacturing issue, the device has a lower value than the value set on the vaporizer dial. It turned out that an anesthetic of the concentration could be supplied. For this reason, we provide information to our customers based on the manufacturer's information, and we also inspect the vaporizer and, if a problem is identified, In the same way, we will carry out recovery work to replace the vaporizer. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: (1) anesthetic aging for Deathfluran (2) anesthetic aging for Sepbofluran (3) Anesthetics for isofluran Device Sales name: (1) TEC6 plus vaporized Death full run (2) TEC800 Series A vaporizer Sevofulrun (3) TEC800 Series A vaporizer Isofuru Run |
| Manufacturer | GE Healthcare Japan Co., Ltd. |
| Models | AESD01016, AESB23021, SQBD02531, SQBC05276, AESC25025, SQBC00076, SQBD02212, SQBD03903, AESD08016, AESB24010, AESC10002, AESC32002 and 1451 more |
| Date | Jan 10, 2025 |
| 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