The Recall Desk
HighFDA (Devices)·Z-1471-2023·Announced 2023-05-03

Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect

Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.

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: FDA Class II medical device recall involving a patient monitoring system with risk of inaccurate ECG waveform display. The product is used for high-risk cardiac monitoring, but no illnesses or injuries have been reported, placing this in the risk-of-harm category without documented harm.

Plain-English summary

The Draeger Infinity CentralStation (ICS) is a centralized patient monitoring system used in hospitals and clinical settings to monitor cardiac, respiratory, and other vital parameters in adult, pediatric, and neonatal patients. Software versions VG2.1.3 and lower contain a defect that drops peaks on narrow waveforms, causing ECG waveforms with narrow or high frequency QRS complexes to display or print with QRS amplitudes intermittently lower than actual values.

This software defect affects approximately 6,803 systems worldwide with US nationwide distribution. The issue can result in displayed cardiac waveforms that do not accurately represent the patient's actual ECG, potentially compromising the clinical accuracy of cardiac monitoring.

Hospitals and clinical facilities using Draeger Infinity CentralStation systems with software versions VG2.1.3 or lower should contact Draeger Medical Systems, Inc. for instructions on software updates or corrective actions. No injuries or illnesses have been reported as of the recall notice date.

The recalled product

Product
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Manufacturer
Draeger Medical Systems, Inc.
Category
Medical Device — Patient Monitoring / Cardiac
Hazard
  • ecg-waveform-accuracy
  • monitoring-failure

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)

  • UDI-DI: 04049098001878
  • All Systems Running Software versions: ICS VG2.1.3 and lower

Distribution

Distributed nationwide across the United States.

Related recalls

Same category