REMstar REMstar Pro C-Flex+, System One 60 Series, ItalyRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959048218), received between Jul 17, 2023 and Jul 17, 2023 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K021861); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJul 17, 2023Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED HEAD CANCER. THE PATIENT REPORTED TO RECEIVE MEDICAL INTERVENTION AND HAD SURGERY RELATED TO THE CANCER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer

  MAUDE report 17335674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021861. One submission often covers many models, so check the product and lot details in each record.

• Z-1069-2008 · Oct 15, 2007 · Terminated
  Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS;