FDA Medical Device Recalls (openFDA)
Draeger Medical Systems, Inc.: 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
- Recall number
- Z-1471-2023
- Recalling firm
- Draeger Medical Systems, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2023-04-05
- Posted
- 2023-04-27
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- 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
- Quantity
- 6803 systems
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower
- 510(k) numbers
- ["K151860"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3005783425
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28