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BiPAP autoSV Advanced System One 60 Series
Respironics, Inc. · Model BiPAP autoSV Advanced, w/HT Humid, St Tube, 60 Series, CA · UDI-DI 00606959029613
10
510(k) clearances
11,710
Adverse events (393 deaths)
21
Recalls
31
Facilities
Description
BiPAP autoSV Advanced System One 60 Series Ventilatory Support System with Heated Tube Humidifier and Standard Tube, Canada
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-15 | BMC Medical Co., Ltd. | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse |
| 2025-05-09 | Philips Respironics, Inc. | This device does not indicate for use in patients with respiratory failure. |
| 2025-05-09 | Philips Respironics, Inc. | This device does not indicate for use in patients with respiratory failure. |
| 2024-04-01 | Philips Respironics, Inc. | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respira |
| 2024-03-26 | Philips Respironics, Inc. | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, res |
| 2024-03-26 | Philips Respironics, Inc. | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, res |
| 2022-08-26 | Philips Respironics, Inc. | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 | Philips Respironics, Inc. | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 | Philips Respironics, Inc. | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 | Philips Respironics, Inc. | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.