Vital Sync VITALSYNCSW03 (UDI 10884521844940)Recalls & reported problems
Covidien LP · VITAL SYNC V3 SOFTWARE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521844940), received between Nov 26, 2024 and Nov 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jan 30, 2026Open, Classified
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Z-1557-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2024Computer Software Problem; No Display/Image; Computer Software Problem; No Display/Image
ACCORDING TO THE REPORTER, PRIOR TO USE, THE SCREEN IN TELEMETRY WAS SILENT AND NOT DISPLAYING REMOTE SURVEILLANCE SYSTEM. THE CUSTOMER WAS INSTRUCTED TO CHANGE THE INPUT ON THE MONITOR AND TO TURN UP THE VOLUME TO HEAR ALERTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20779513 ↗
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- Midmark Midmark Digital ECGCardioline SPA · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall1 report
- Vital Sync VITALSYNCSW03Covidien LP · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 recall1 report
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- BioButton v3 (BBN-r, different batch) BIOST06040Biointellisense, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall0 reports
- Patient Monitor elite V5Edan Instruments, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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