Vital Sync VITALSYNCSW03 (UDI 10884521835870)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521835870), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer System Security Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K160718); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160718. One submission often covers many models, so check the product and lot details in each record.

• Z-1557-2026 · Jan 30, 2026 · Open, Classified
  HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital