Somnostar 16610Recalls & reported problems
Carefusion Corporation · HEADBOX ASSEMBLY · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846446020076), received between Jan 25, 2019 and Jan 25, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Overheating of Device2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2019Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE AMPLIFIER BECOMES VERY HOT TO TOUCH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE INCIDENT; HOWEVER, THERE WAS NO END USER AND PATIENT HARM ASSOCIATED IN THIS EVENT. THE SUSPECT AMPLIFIER HAS BEEN RETURNED TO VYAIRE FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8279908 ↗MalfunctionJan 25, 2019Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE AMPLIFIER BECOMES VERY HOT TO TOUCH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE INCIDENT; HOWEVER, THERE WAS NO END USER AND PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8279651 ↗
Other Standard Polysomnograph With Electroencephalograph devices
- Micromed SD LTM 64 PLUSMicromed SPA · Standard Polysomnograph With Electroencephalograph1 recall0 reports
- Alice 6 Alice 6 LDxS Headbox, NARespironics, Inc. · Standard polysomnograph with electroencephalograph2 reports
- Alice 6 Alice 6, Base Station, LDx, NARespironics, Inc. · Standard polysomnograph with electroencephalograph1 report
- Somnostar 28483-001Carefusion Corporation · Standard Polysomnograph With Electroencephalograph1 report
- Alice 6 Alice 6, Base Station, LDx, INTLRespironics, Inc. · Standard polysomnograph with electroencephalograph1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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