Welch Allyn, Inc. 901137 (REF SCSYS-IED-LBFAX)Recalls & reported problems

Welch Allyn, Inc. · Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0 hard wired patient monitoring slots and 24 telemetry channels (dual display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment mon · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00732094262131), received between May 20, 2021 and Sep 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Computer Software Problem1
Connection Problem1
Device Alarm System1
No Audible Alarm1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2025Connection Problem; Connection Problem
THE CUSTOMER REPORTED A LOST CONNECTION, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23178936 ↗
MalfunctionAug 13, 2024No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT THE SURVEYOR CENTRAL DIDN'T PROVIDE AN ALARM. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19970766 ↗
MalfunctionMay 20, 2021Device Alarm System; Computer Software Problem; Device Alarm System; Computer Software Problem
THE CUSTOMER REPORTED A MALFUNCTION OF THE SURVEYOR CENTRAL DEVICE WHICH EMITTED A LOUD CONTINUOUS SOUND, IN A SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER THEY CONFIRMED THAT THE CENTRAL STATION WAS NOT PICKING UP THE TELEMETRY DEVICE. THE DEVICE WAS IN USE FOR CONTINUOUS PATIENT MONITORING, AND THE CUSTOMER REPORTED THAT THE MALFUNCTION RESULTED IN THE PATIENT NOT BEING MONITORED. THE CUSTOMER CONFIRMED THAT THERE WAS NO ASSOCIATED PATIENT INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11857006 ↗

Device details

UDI-DI	`00732094262131`
Brand	Welch Allyn, Inc.
Model	901137
Catalog no.	SCSYS-IED-LBFAX
Company	Welch Allyn, Inc.
Product code	MHX · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 27, 2022

Device type (GMDN): Centralized patient monitor

A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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