Vital Sync VITALSYNCSW01 (UDI 10884521812208)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521812208), received between Jun 24, 2024 and Jun 24, 2024 — 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.

• 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 ↗

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