International safety notice
Recently, the Japan Medical Devices Agency (Independent Administrative Agency) has issued a minor change notification dated November 26, 2014 regarding the product concerned. Regarding the change in raw materials for Ikorich T-70, it is not a minor change, but a change that corresponds to an application for approval of a partial change in approved items. We have received some comments that the changes have been made. Due to the occurrence of prolapse, dental treatment and We will voluntarily collect them from medical institutions that provide obstetrics and gynecology treatment.
Japan / PMDA Recalls · JPN · May 22, 2023
Key facts
| Title | Recently, the Japan Medical Devices Agency (Independent Administrative Agency) has issued a minor change notification dated November 26, 2014 regarding the product concerned. Regarding the change in raw materials for Ikorich T-70, it is not a minor change, but a change that corresponds to an application for approval of a partial change in approved items. We have received some comments that the changes have been made. Due to the occurrence of prolapse, dental treatment and We will voluntarily collect them from medical institutions that provide obstetrics and gynecology treatment. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Mixed gas anesthesia machine Sales name: Cedent Psycho Rich T-70 |
| Manufacturer | Sekimura Co., Ltd. |
| Models | N04310, N01317, N02291, N01109, N02247, N02260, N03590, N01216, N03817, N04563, N01736, N01740 and 1485 more |
| Date | May 22, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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