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AF531
Respironics, Inc. · Model AF531 EE Leak1 NE 4PT Headgear, Single Use,Small, US · UDI-DI 00606959012011
MNS
Prescription
10
510(k) clearances
11,195
Adverse events (392 deaths)
21
Recalls
32
Facilities
Description
AF531 Mask with Entrainment Elbow, Leak 1, Nebulizing Elbow, 4 Point Headgear, Single Use, USA, Small
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.