BCI 6004001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10610586036583), received between Aug 13, 2021 and Jan 27, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE GAVE ERROR CODE E4 AND E20. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259149 ↗
• MalfunctionAug 30, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAS AN ERROR CODE UPE-20, WILL NOT PUMP UP THE CUFFS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322360 ↗
• MalfunctionMar 19, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT A SMITHS MEDICAL PATIENT MONITORING/BCI BLOOD PRESSURE MONITOR MINI-TORR PLUS - 6004 UNIT WAS NOT TURNING ON FULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13822147 ↗
• MalfunctionMar 12, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT A SMITHS MEDICAL PATIENT MONITORING/BCI BLOOD PRESSURE MONITOR MINI-TORR PLUS - 6004 UNIT WAS NOT TURNING ON FULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743716 ↗
• MalfunctionDec 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE TAKES BLOOD PRESSURE INTERMITTENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025851 ↗
• MalfunctionAug 25, 2021Power Problem; Power Problem

  INFORMATION RECEIVED A SMITHS MEDICAL PATIENT MONITORING/BCI BLOOD PRESSURE MONITOR MINI-TORR PLUS - 6004 UNIT WILL NO POWER ON.

  Patient problems: Insufficient Information

  MAUDE report 12368447 ↗
• MalfunctionAug 13, 2021Device Alarm System; Device Alarm System

  INFORMATION RECEIVED A SMITHS MEDICAL PATIENT MONITORING/BCI BLOOD PRESSURE MONITOR MINI-TORR PLUS - 6004 HAS ERROR CODES 4,20. NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321702 ↗
• MalfunctionAug 13, 2021Device Alarm System; Device Alarm System

  INFORMATION RECEIVED A SMITHS MEDICAL PATIENT MONITORING/BCI BLOOD PRESSURE MONITOR MINI-TORR PLUS - 6004 REVEALED ERROR CODE 13 INDICATING LEAK.

  Patient problems: Insufficient Information

  MAUDE report 12321266 ↗

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,