Welch Allyn, Inc. 901138 (REF SUR12-LDH-BXXAX)Recalls & reported problems

Welch Allyn, Inc. · Surveyor S12 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, resistive color touchscreen 11.6 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 5 wire ECG patient cable with clip ends; Edwards invasive blood pressure cable; No cardiac output cable; No printer; LAN; No mounting options · Class 2

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

Mar 31, 2021Terminated
Devices do not meet IEC 60601-2-27 requirements as labeled.
Z-1484-2021 · Root cause: Process control · FDA record ↗

Device details

UDI-DI	`00732094261745`
Brand	Welch Allyn, Inc.
Model	901138
Catalog no.	SUR12-LDH-BXXAX
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): General-purpose multi-parameter bedside monitor

An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.