BCI 6004006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586036606), received between Aug 31, 2022 and Aug 31, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031742); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 31, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE PRESENTED WITH AN ERROR CODE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326691 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031742. One submission often covers many models, so check the product and lot details in each record.

• Z-1649-2008 · Apr 2, 2008 · Terminated
  BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,