BiPAP ST 00 (REF 1061P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959039162), received between Mar 23, 2022 and Mar 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

1 other recall cover devices cleared under the same FDA submission (K102465); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND CONTAMINATED SOUND FOAM AND OTHER PARTS WERE CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862886 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102465. One submission often covers many models, so check the product and lot details in each record.

• Z-1973-2021 · Jun 14, 2021 · Open, Classified
  DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respiron