Somnostar 28483-001Recalls & reported problems
Carefusion Corporation · SOMNOSTAR Z4 SYSTEM VER 11 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846446032604), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Computer Software 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
- Computer Software Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THE ISSUE WITH THE SOFTWARE INDICATING THAT THE HEART RATE (HR) READING IS UNUSUALLY BELOW AVERAGE OR DESCRIBES AS INCORRECT VALUES. THE CUSTOMER REPORTED THAT THE MEDICAL DIRECTOR OF THE FACILITY NOTICED THAT THE HR OF 27 BEATS PER MINUTE (BPM) AND WAS CONSIDERING TO REFER TO A CARDIOLOGIST BASED ON THE TEST RESULTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8745727 ↗
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
- Somnostar 16610Carefusion Corporation · Standard Polysomnograph With Electroencephalograph2 reports
- Alice 6 Alice 6, Base Station, LDx, NARespironics, Inc. · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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