Food, drugs, devices › Philips Respironics, Inc.
Device recall: Philips Respironics Amara View Minimal Contact Full-Face Mask
Philips Respironics, Inc. (Murrysville, PA) initiated this device recall on 6 Sep 2022; FDA lists 5 product records under event 90705, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips Respironics, Inc. has 26 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Respironics, Inc., Murrysville, PA.
Reason for recall
"No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes."
Distribution
"Worldwide distribution - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1780-2022 | Philips Respironics Amara View Minimal Contact Full-Face Mask | 5,661,639 units | Class I | Ongoing | 12 Oct 2022 |
| Z-1781-2022 | Philips Respironics DreamWear Full Face Mask | 9,191,280 units | Class I | Ongoing | 12 Oct 2022 |
| Z-1782-2022 | DreamWisp Nasal Mask with Over the Nose Cushion | 930,813 units | Class I | Ongoing | 12 Oct 2022 |
| Z-1783-2022 | Wisp and Wisp Youth Nasal Mask | 6,237,558 units | Class I | Ongoing | 12 Oct 2022 |
| Z-1784-2022 | Therapy Mask 3100 NC/SP | 42,954 units | Class I | Ongoing | 12 Oct 2022 |
Context
Other enforcement events for Philips Respironics, Inc.
All 26 events for Philips Respironics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.