Vital SyncRecalls & reported problems across all models

We found 9 models of Vital Sync by Covidien LP in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2024 and Jul 8, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (3 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Vital Sync recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 6 of these models · Recall details · FDA record ↗

Most reported Vital Sync problems

Vital Sync models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vital Sync VITALSYNCSW03

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 recall1 report
• Vital Sync VITALSYNCSW03

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 recall1 report
• Vital Sync VITALSYNCSW03

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 recall0 reports
• Vital Sync VITALSYNCSW04

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 recall0 reports
• Vital Sync VITALSYNCSW03

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 recall0 reports
• Vital Sync VITALSYNCSW04

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 recall0 reports
• Vital Sync VITALSYNCSW01

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 report
• Vital Sync VITALSYNCSW01

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 report
• Vital Sync VITALSYNCSW03

  TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
  1 report

Recent Vital Sync adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Computer System Security Problem; Computer System Security Problem

  IT WAS REPORTED THAT PRIOR TO USE, A VULNERABILITY WITH THE REMOTE SURVEILLANCE CYBERSECURITY PLATFORM WAS IDENTIFIED, AND THE CYBER SECURITY PLATFORM ISSUED AN ALERT REGARDING THIS VULNERABILITY ON ALL EIGHT SERVERS SERVING THE SITE. THE SITE DETERMINED THAT THE PROGRAM NEEDED TO BE UPDATED TO THE MOST CURRENT VERSION TO REDUCE THE VULNERABILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438420 ↗
• 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 ↗
• MalfunctionJun 24, 2024Computer System Security Problem; Computer System Security Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD MIRTH CONNECT VULNERABILITY AND NEEDED ASSISTANCE TO BE CORRECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19599754 ↗
• MalfunctionMar 28, 2024Device Alarm System; Computer Software Problem; Labelling, Instructions for Use or Training Problem; Device Alarm System; Computer Software Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, MULTIPLE TILES HAD MULTIPLE PATIENTS ADMITTED TO THEM AND ALARMS FOR THE CURRENT PATIENT DID NOT ALERT ON THE TILE DUE TO MANY PATIENTS AND THE ALARMS WERE GETTING PUSHED OUT OF THE TILE. IT WAS FOUND OUT THAT PATIENTS WERE NOT GETTING DISCHARGE FROM THE REMOTE SURVEILLANCE SYSTEM BEFORE NEW PATIENT WAS ADMITTED. AN INTERNAL STAFF WAS ON THE SITE AND PATIENTS THAT WERE ASSIGNED TO THE SAME TILE WERE DISCHARGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995495 ↗
• MalfunctionMar 7, 2024Computer Software Problem; Computer Software Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE REMOTE SURVEILLANCE SYSTEM HAD NO ANY AUDIBLE ALARMS ON THE CNS. TROUBLESHOOTING WAS REMOTED INTO, LOOKED AT THE TILES FOR ROOMS. IT WAS COLOR RED AND ORANGE BUT THERE WAS NO AUDIBLE ALERT. CLICKED ON THE TILE AND SEE THAT THE ALARM WAS SILENCED. THE RESOLUTION WAS TO UPDATE THE OPERATING SYSTEM TO CORRECT THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862687 ↗

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