Welch Allyn, Inc. 901137 (REF SCSYS-IED-KBFAX)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; 8 hard wired patient monitoring slots and 16 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: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00732094262148), received between May 14, 2021 and May 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (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.

Most reported problems

Device problems

Unintended Application Program Shut Down1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 14, 2021Unintended Application Program Shut Down; Unintended Application Program Shut Down
A CUSTOMER REPORTED A MALFUNCTION WITH THEIR SURVEYOR CENTRAL DEVICE. THEY REPORTED THAT THE PROCESS THAT MANAGES THE DISPLAY OF THE CENTRAL USER INTERFACE WAS REPEATEDLY CRASHING AND RESTARTING. SUBSEQUENTLY THE DEVICE COULD NOT BE RESTARTED AT ALL, LEAVING THE USER WITHOUT THE PATIENT MONITORING VISUALIZATION. A REVIEW OF THE DEVICE LOG FILES BY A HILLROM TECHNICIAN IDENTIFIED THAT THE ISSUE BEGAN ON THE 26TH APRIL 2021. THE CUSTOMER'S SURVEYOR CENTRAL SYSTEM WAS COMPOSED OF A SINGLE NODE, CONNECTED TO 6 S12 BEDSIDE MONITORS AND 18 S4 TELEMETRIES. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826578 ↗

Device details

UDI-DI	`00732094262148`
Brand	Welch Allyn, Inc.
Model	901137
Catalog no.	SCSYS-IED-KBFAX
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 28, 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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