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Amara View Amara View Mask with Headgear, Medium, USRecalls & reported problems

Respironics, Inc. · Amara View Mask with Headgear, USA, Medium · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959009202), received between Nov 9, 2022 and Nov 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WAS USING AN AMARA VIEW MASK WITH MAGNETIC CLIPS WHILE HAVING A COCHLEAR IMPLANT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. THE AMARA VIEW INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE MASK ASSEMBLY CONTAINS MAGNETS. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. KEEP UNASSEMBLED MAGNETIC HEADGEAR CLIPS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL SWALLOWING, SEEK MEDICAL ASSISTANCE IMMEDIATELY. THIS REPORT WILL BE FILED AS AN INITIAL-FINAL REPORT. WE WILL CONTINUE TO MONITOR THESE COMPLAINTS REGARDING MAGNETS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, AN ADDITIONAL REPORT WILL BE FILED. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15759369 ↗

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Sources and updates

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