VistaCenter 6200-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850490007139), received between Jun 3, 2020 and Jun 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (1 report).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 21, 2020Terminated

   A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.

   Z-2537-2020 · Root cause: Software Design Change · Recall details · FDA record ↗

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 3, 2020Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  A HEALTHCARE PROVIDER NOTICED A PATIENT HAD A LOWERED SPO2 READING THAT SHOULD HAVE TRIGGERED A VISTACENTER NOTIFICATION TO THE CARE TEAM, BUT NO NOTIFICATION WAS FOUND. THE PATIENT'S OXYGEN SATURATION RECOVERED, BUT WAS SIGNIFICANTLY LOW, EXPOSING THE PATIENT TO POTENTIAL HYPOXIA FOR A SHORT WINDOW OF TIME.

  Patient problems: Hypoxia

  MAUDE report 10116393 ↗