BCI 920654230ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586037344), received between Aug 31, 2022 and Apr 20, 2023 — classified as 2 malfunctions.

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

43 other recalls cover devices cleared under the same FDA submission (K030407); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Defective Alarm; Unable to Obtain Readings; Defective Alarm; Unable to Obtain Readings

  IT WAS REPORTED THAT IF PATIENT GOES INTO A FIB, THE DEVICE WILL NOT REGISTER OR ALARM. NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16780680 ↗
• MalfunctionAug 31, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THERE WAS A PRINTER ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328942 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030407. One submission often covers many models, so check the product and lot details in each record.

• Z-2379-2018 · Nov 29, 2017 · Terminated
  BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain func
• Z-1692-2015 · Mar 21, 2015 · Terminated
  Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
• Z-0918-2010 · Jan 15, 2010 · Terminated
  9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).
• Z-1326-2009 · Dec 22, 2008 · Terminated
  Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335
• Z-1089-2007 · Jun 5, 2007 · Terminated
  BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
• Z-0237-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0240-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0227-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0235-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0239-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0231-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0222-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0229-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0228-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0225-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main

…and 28 more.