Vyaire V-178500Recalls & reported problems
Jaeger Medical GmbH · Vyntus BODY · Class 2
All models of Vyaire (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04250892904672), received between Sep 27, 2023 and Sep 27, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (4 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
- Mechanical Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER COMPLAINED THAT THE US SENSOR DETACHES EASILY. NO PATIENT INJURIES HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17827558 ↗MalfunctionSep 27, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER CALLED REPORTING THAT THE BODY CABIN IS NOT RECOGNIZED BY THE SES SOFTWARE. BEFORE THE FAILURE MESSAGE APPEARED THE USS MODULE FELL DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17827435 ↗MalfunctionSep 27, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER CALLED AND REPORTED THAT THE USS FELL FROM THE FPV, CAUGHT BY AND HANGING ON THE CABLE. AFTER INSTALLING THE USS AGAIN, THE VYNTUS BODY CABIN SHOWED THE FOLLOWING BOOT RESULTS "BLUE/ORANGE BLINKING LED STRIP" AND THE ERROR MESSAGE "COMMUNICATION, DEVICE NOT FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17827353 ↗MalfunctionSep 27, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER CALLED AND COMPLAINED ABOUT THE FIXATION OF THE US SENSOR. A FALLING US SENSOR CAUSED MOST PROBABLY THE BREAKDOWN OF THE DEVICE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17824876 ↗
Other Calculator, Pulmonary Function Data devices
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- Vyaire V-178500-13Jaeger Medical GmbH · Calculator, Pulmonary Function Data6 reports
- Vyaire V-178603Jaeger Medical GmbH · Calculator, Pulmonary Function Data3 reports
- Vyaire V-178601Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
- Jaeger 172520Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
- Jaeger V-175423Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
- Vyaire V-707960Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
- Vyaire V-178602Jaeger Medical GmbH · Calculator, Pulmonary Function Data1 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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