International safety notice
Foreign manufacturers are manufacturing motor assemblies that may contain incompatible plastic materials in a limited number of devices. was determined to be included. A sudden failure of the equipment in use may cause it to stop functioning or generate gas that does not normally occur. The company will provide information requesting the discontinuation of use of the device and will replace the device. As a result, we have decided to take the same measures.
Japan / PMDA Recalls · JPN · Sep 7, 2022
Key facts
| Title | Foreign manufacturers are manufacturing motor assemblies that may contain incompatible plastic materials in a limited number of devices. was determined to be included. A sudden failure of the equipment in use may cause it to stop functioning or generate gas that does not normally occur. The company will provide information requesting the discontinuation of use of the device and will replace the device. As a result, we have decided to take the same measures. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Artificial respirator for adults Sales name: (1) BiPAP A40 System Silver Series (2) OmniLab system |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | V288751652BA7, V2887096858D7, V28875019F61F, V2887515364F9, V304885482F47, V29084386FE5E, V288750341E4A, V28875159CBA3, V30396087FE7A, V305010732529, V305014012852, V30560612918A and 183 more |
| Date | Sep 7, 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