Draeger Infinity CentralStation (ICS), centralized… recallZ-1471-2023 · Draeger Medical Systems, Inc. · initiated Apr 5, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Draeger Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

FDA root cause category: Software design

What the company is doing

An Urgent - Medical Device Correction notification letter dated March 2023 was sent to customers. Actions to be taken: Until the corrected software is available and installed, clinicians should utilize the Draeger ICS/MSOO Instructions For Use while applying any additional means of standard practices for assessment of patients with unusually high and/or low QRS amplitudes. Clinicians should combine this information with physical assessment of the patient and follow standard clinical practice. Please ensure that all users of the affected products listed above and other people within your organization are made aware of this Important Safety Notice. If you have provided the products to third parties, please forward a copy of this information to them. Actions being taken by the Company: We are currently working on releasing updated software (ICS VG4/M300 VG3) to resolve the issue which will be provided to you at no charge; targeted for the third quarter of 2023. Your local Drager Service representative will contact you to arrange a date for the software update to be performed once the software is available. Please keep this information at least until the software update has been completed. Please also complete and return the Customer Acknowledgment Card provided to confirm to us that you have received this information. We regret any inconvenience this may cause. We consider this notice a necessary measure to increase patient safety. We thank you for your support. If you have any questions regarding the operation of the Product, please contact Drager Service Technical Support between the hours of 8:00 AM - 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1). An Urgent - Medical Device Correction UPDATE TO: Urgent - Medical Device Correction released March 2023 relating to software on the Infinity CentralStation dropping peaks on narrow waveforms causing the Infinity M300 to fail clauses 201.12.1.101 and 201.12.1.101.8 within IEC 60601-2-27 Frequ

Recall details

Recall number: Z-1471-2023
Status: Open, Classified
Initiated by the company: Apr 5, 2023
Posted by the FDA: Apr 27, 2023
Recalling firm: Draeger Medical Systems, Inc.
Quantity: 6803 systems
Product code: MHX
FDA submissions: K151860
Distribution: Worldwide - US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Infinity CentralStation Wide (confi) MS26800
Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
3 recalls1 death31 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91938).

Z-1472-2023 · Open, Classified
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication o…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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