The Recall Desk
HighFDA (Devices)·Z-0974-2019·Announced 2019-03-13

Draeger Infinity Delta Patient Monitors Recalled for Cybersecurity Vulnerabilities

Draeger Medical Systems is recalling Infinity Delta patient monitors due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (loss of functionality/communication) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Draeger Medical Systems, Inc. is recalling the Infinity Delta Family patient monitors, including the Delta, Delta XL, Kappa, Omega, and Omega S models. The recall covers 10,699 units distributed nationwide in the United States, including Puerto Rico. The affected devices are intended for use on adult, pediatric, and neonatal populations, with specific parameter limitations for certain age groups.

The recall is being conducted due to cybersecurity vulnerabilities in the device software. These vulnerabilities may cause the monitors to reboot, lose functionality, and/or lose communication. The recall includes all software versions and all serial numbers of the affected models.

Healthcare facilities and consumers should contact Draeger Medical Systems for instructions on how to address the cybersecurity vulnerabilities and ensure the continued safe operation of the devices.

The recalled product

Product
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended fo
Manufacturer
Draegar Medical Systems, Inc.
Category
Medical Device — Patient Monitor
Hazard
Affected units
10,699

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All software versions
  • all serial numbers.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Draegar Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Draegar Medical Systems, Inc.

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Same hazard · cybersecurity vulnerability

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