Surveyor S12 SUR12-RAG-EXABXRecalls & reported problems

Mortara Instrument, Inc. · Patient Monitor · Class 2

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

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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

Device details

UDI-DI	`00817655021553`
Brand	Surveyor S12
Model	SUR12-RAG-EXABX
Company	Mortara Instrument, Inc.
Product code	MHX · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 10, 2023

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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All Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices →

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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