Drager Infinity CentralStation Software Temporary Monitoring Functionality Loss

Plain-English summary

Drager Medical Systems, Inc. is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a software issue that causes temporary loss of central monitoring functionality. The software is used for patient monitoring in conjunction with Infinity M300 wireless telemetry devices.

The temporary loss of central monitoring functionality could prevent healthcare providers from monitoring patients through the central station. Approximately 1,950 units have been distributed worldwide, including 376 in the United States across multiple states and 1,574 outside the United States.

The FDA has classified this as a Class II recall. Healthcare facilities using affected software versions should verify that central monitoring functionality is working properly and may contact Drager Medical Systems for information about available updates.

The recalled product

Product

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

Manufacturer

Draegar Medical Systems, Inc.

Category

Medical Device — Patient Monitoring / Telemetry

Hazard

• software-malfunction
• loss-of-monitoring

Is your product affected?

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

Distribution

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