Vital Sync VITALSYNCSW01 (UDI 10884521780668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521780668), received between Mar 28, 2024 and Mar 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software 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.

• 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 ↗

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