Model note · Cardiac Monitor

Draeger Infinity Delta, Delta XL and Kappa patient monitors

Name: Draeger Infinity Delta, Delta XL and Kappa patient monitors
Brand: Draeger Infinity Delta

The Infinity Delta family (Delta, Delta XL and Kappa) are Draeger modular bedside monitors for adults, children and neonates. They take plug in pods and modules, including the Scio gas module for CO2, N2O, O2 and anaesthetic agents, and connect over the Infinity Network to central stations and the R50 recorder. Two things matter most in the field. Software VF10.0 with a Scio module could fail to sound the low O2 alarm. Earlier software had cybersecurity weaknesses fixed in VF10.1, a recall that covered 10,699 monitors.

Start 7-day free trial Ask Essentia about the Cardiac Monitor

The model

Maker, model and type.

Maker: Draeger Medical Systems, Inc.
Model: Infinity Delta, Delta XL and Kappa patient monitors (software VF9.1 to VF10.1)
Device type: Cardiac Monitor
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
FDA classification and clearances	Physiological patient monitor with arrhythmia detection, 21 CFR 870.1025, Class II, product code MHX; K060039 (2006, VF6), K070566 (2007), K152407 (23 September 2015, VF9.1)	Source
Parameters	Heart rate, respiration, invasive and non-invasive pressure, arrhythmia, temperature, cardiac output, SpO2, pulse rate, apnea, ST and 12 lead ST analysis, tcpO2/tcpCO2, EEG, FiO2, etCO2, respiratory mechanics, anaesthetic agents, neuromuscular transmission	Source
Patients	Adult, pediatric and neonatal, except cardiac output, ST analysis and arrhythmia (adult and pediatric only); tcpO2 in neonates only when not under gas anaesthesia	Source
Scio gas module	Samples breathing gas in adults and children; measures CO2, N2O, O2 and one agent (halothane, isoflurane, enflurane, sevoflurane or desflurane) in any mixture	Source
VF9.1 changes	Alternative etCO2 solution for Delta and Delta XL, plus software enhancements for all three models	Source
Connectivity	Visual and audible alarms beyond preset limits; timed or alarm recordings to an R50 bedside recorder directly or over the Infinity Network	Source

Recalls

Known FDA recalls.

Z-0974-20192019-02-08
Cybersecurity vulnerabilities could cause reboots, lost functions or lost communication; fixed by VF10.1 (10,699 monitors).
FDA record
Z-1772-20172017-03-28
VF10.0 with Scio gas modules: low O2 alarm may not sound (2,156 devices).
FDA record
Z-3047-20112011-07-29
Delta portable: keys may stop working or activate by themselves; may discharge a patient automatically.
FDA record
Z-2283-20102010-06-04
Delta and Gamma XXL: membrane switch panel malfunction with the same effect.
FDA record

Safety

Safety warnings from the record.

With software VF10.0 and a Scio module, a set low O2 alarm could stay silent although the measured O2 was below the limit. Source
Cybersecurity weaknesses in earlier software could make the monitor reboot, lose functions or lose communication; 10,699 monitors were in the 2019 recall. Source

Sources

Where this note comes from.

Not covered: The Infinity Delta instructions for use and service manual were not read, so screen size, battery, weight, parameter accuracies and error messages are not included. The low O2 alarm acceptance check is a BMEssentia suggestion drawn from the recall, not a Draeger procedure.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

Cardiac Monitor