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Philips Respironics, Inc.

82 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilat recall (Z-1646-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use venti recall (Z-1647-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventil recall (Z-1648-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-us recall (Z-1649-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilat recall (Z-1614-2026)Philips Respironics, Inc.2026-03-26
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use venti recall (Z-1615-2026)Philips Respironics, Inc.2026-03-26
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventil recall (Z-1616-2026)Philips Respironics, Inc.2026-03-26
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-us recall (Z-1617-2026)Philips Respironics, Inc.2026-03-26
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are recall (Z-0481-2026)Philips Respironics, Inc.2025-11-07
DreamStation Auto CPAP. Non-Continuous Ventilator. recall (Z-2227-2025)Philips Respironics, Inc.2025-08-08
DreamStation Auto BiPAP. Non-Continuous Ventilator. recall (Z-2228-2025)Philips Respironics, Inc.2025-08-08
DreamStation Auto. Non-Continuous Ventilator. recall (Z-2229-2025)Philips Respironics, Inc.2025-08-08
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediat recall (Z-2035-2025)Philips Respironics, Inc.2025-07-02
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pe recall (Z-2036-2025)Philips Respironics, Inc.2025-07-02
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of t recall (Z-2037-2025)Philips Respironics, Inc.2025-07-02
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, recall (Z-0290-2025)Philips Respironics, Inc.2024-11-13
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, recall (Z-0291-2025)Philips Respironics, Inc.2024-11-13
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-i recall (Z-0292-2025)Philips Respironics, Inc.2024-11-13
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, recall (Z-0293-2025)Philips Respironics, Inc.2024-11-13
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of recall (Z-0294-2025)Philips Respironics, Inc.2024-11-13
Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation o recall (Z-0295-2025)Philips Respironics, Inc.2024-11-13
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilatio recall (Z-0296-2025)Philips Respironics, Inc.2024-11-13
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux recall (Z-2942-2024)Philips Respironics, Inc.2024-09-05
Trilogy Evo Universal Ventilator, Model No. DS2000X11B recall (Z-2943-2024)Philips Respironics, Inc.2024-09-05
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B T recall (Z-2944-2024)Philips Respironics, Inc.2024-09-05
BiPAP V30 Auto Ventilator, Part Number 1111178 recall (Z-1812-2024)Philips Respironics, Inc.2024-05-24
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 recall (Z-1813-2024)Philips Respironics, Inc.2024-05-24
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111 recall (Z-1814-2024)Philips Respironics, Inc.2024-05-24
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111 recall (Z-1817-2024)Philips Respironics, Inc.2024-05-23
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult pat recall (Z-1499-2024)Philips Respironics, Inc.2024-04-17
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult pa recall (Z-1500-2024)Philips Respironics, Inc.2024-04-17
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult recall (Z-1501-2024)Philips Respironics, Inc.2024-04-17
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult recall (Z-1502-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adul recall (Z-1503-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult p recall (Z-1504-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for recall (Z-1505-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13 recall (Z-0638-2024)Philips Respironics, Inc.2024-01-04
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Par recall (Z-2631-2023)Philips Respironics, Inc.2023-09-28
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions recall (Z-2106-2023)Philips Respironics, Inc.2023-07-07
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, recall (Z-1649-2023)Philips Respironics, Inc.2023-06-02
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X recall (Z-1650-2023)Philips Respironics, Inc.2023-06-02
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200 recall (Z-1651-2023)Philips Respironics, Inc.2023-06-02
Trilogy Evo Universal Ventilator, Model Number DS2000X11B recall (Z-1652-2023)Philips Respironics, Inc.2023-06-02
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S1 recall (Z-1322-2023)Philips Respironics, Inc.2023-04-06
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN recall (Z-1287-2023)Philips Respironics, Inc.2023-04-03
Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X1 recall (Z-1288-2023)Philips Respironics, Inc.2023-04-03
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B recall (Z-1289-2023)Philips Respironics, Inc.2023-04-03
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 10542 recall (Z-0882-2023)Philips Respironics, Inc.2023-01-06
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA10 recall (Z-0883-2023)Philips Respironics, Inc.2023-01-06
Philips Garbin Ventilator, Model Number 1058180B recall (Z-0884-2023)Philips Respironics, Inc.2023-01-06
Philips Respironics Amara View Minimal Contact Full-Face Mask recall (Z-1780-2022)Philips Respironics, Inc.2022-09-30
Philips Respironics DreamWear Full Face Mask recall (Z-1781-2022)Philips Respironics, Inc.2022-09-30
DreamWisp Nasal Mask with Over the Nose Cushion recall (Z-1782-2022)Philips Respironics, Inc.2022-09-30
Wisp and Wisp Youth Nasal Mask recall (Z-1783-2022)Philips Respironics, Inc.2022-09-30
Therapy Mask 3100 NC/SP recall (Z-1784-2022)Philips Respironics, Inc.2022-09-30
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with o recall (Z-1654-2022)Philips Respironics, Inc.2022-09-09
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with o recall (Z-1655-2022)Philips Respironics, Inc.2022-09-09
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients w recall (Z-1656-2022)Philips Respironics, Inc.2022-09-09
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patient recall (Z-1657-2022)Philips Respironics, Inc.2022-09-09
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation sup recall (Z-1658-2022)Philips Respironics, Inc.2022-09-09
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ve recall (Z-1659-2022)Philips Respironics, Inc.2022-09-09
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo vent recall (Z-0493-2022)Philips Respironics, Inc.2022-01-22
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilo recall (Z-0494-2022)Philips Respironics, Inc.2022-01-22
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. recall (Z-1956-2021)Philips Respironics, Inc.2021-07-15
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventila recall (Z-1957-2021)Philips Respironics, Inc.2021-07-15
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting recall (Z-1958-2021)Philips Respironics, Inc.2021-07-15
Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Suppor recall (Z-1972-2021)Philips Respironics, Inc.2021-07-13
DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and A recall (Z-1973-2021)Philips Respironics, Inc.2021-07-13
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto recall (Z-1974-2021)Philips Respironics, Inc.2021-07-13
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for recall (Z-0942-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pedi recall (Z-0943-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for ped recall (Z-0944-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatri recall (Z-0945-2020)Philips Respironics, Inc.2020-02-15
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediat recall (Z-0946-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended f recall (Z-0947-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for ped recall (Z-0948-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pedi recall (Z-0949-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is inten recall (Z-0950-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for recall (Z-0951-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for recall (Z-0952-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for ped recall (Z-0953-2020)Philips Respironics, Inc.2020-02-15
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatr recall (Z-0954-2020)Philips Respironics, Inc.2020-02-15

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Every clearance here is in the API, with alerts when new ones post.