International safety notice
General name: (1)-(12) Artificial respirator for adults (13)-(17) Two-phase positive airway pressure unit (18)-(21) Continuous automatic positive airway pressure unit (22)-(24) Continuous positive airway pressure unit Sales name: (1) BiPAP A40 system (2) BiPAP A40 System Silver Series (3) BiPAP autoSV Advanced System One 60 series (4) BiPAP Hybrid A30 (5) OmniLab system (6) Trilogy (7) Trilogy 100 plus (8) Trilogy 200 plus (9) BiPAP Harmony (10) BiPAP autoSV Advanced System One series (11) BiPAP (12) BiPAP Synchrony 2 (13)E30 system (14) Dream Station BiPAP Auto (15) Dream Station BiPAP autoSV (16) BiPAP Auto System One 60 series (17) BiPAP Auto System One series (18) REMstar Auto System One 60 series (19) Dream Station Auto (20) Dream Station Go (21) Remstar Auto PRI System (22) REMstar Pro System One 60 series (23) Dream Station Pro (24) Remstar PRI System
Japan / PMDA Recalls · JPN · Jul 20, 2021
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: (1)-(12) Artificial respirator for adults (13)-(17) Two-phase positive airway pressure unit (18)-(21) Continuous automatic positive airway pressure unit (22)-(24) Continuous positive airway pressure unit Sales name: (1) BiPAP A40 system (2) BiPAP A40 System Silver Series (3) BiPAP autoSV Advanced System One 60 series (4) BiPAP Hybrid A30 (5) OmniLab system (6) Trilogy (7) Trilogy 100 plus (8) Trilogy 200 plus (9) BiPAP Harmony (10) BiPAP autoSV Advanced System One series (11) BiPAP (12) BiPAP Synchrony 2 (13)E30 system (14) Dream Station BiPAP Auto (15) Dream Station BiPAP autoSV (16) BiPAP Auto System One 60 series (17) BiPAP Auto System One series (18) REMstar Auto System One 60 series (19) Dream Station Auto (20) Dream Station Go (21) Remstar Auto PRI System (22) REMstar Pro System One 60 series (23) Dream Station Pro (24) Remstar PRI System |
| Manufacturer | Philips Japan Co., Ltd. |
| Date | Jul 20, 2021 |
| 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