FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
- Recall number
- Z-1822-2024
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
- Status
- Open, Classified
- Initiated
- 2024-04-08
- Posted
- 2024-05-15
- Terminated
- not on file
- Reason
- Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
- Root cause
- Device Design
- Action
- Fresenius Medical issued Urgent Medical Device Correction Letter (FA-2021-33-C_REV B) on 4/8/24. Letter states reason for recall, health risk and action to take: If you experience either failure codes (#206/#208) your machine will continue to operate. The essential performance is not affected. It is therefore important to note that the adjusted pump speed will be maintained by the system. The intended use of the Novalung system is to provide respiratory and cardiopulmonary support by extracorporeal circulation and physiologic gas exchange is not impacted by the flow measurement error messages To correct this issue, FMCRTG will update the sensor box on your Novalung console. An FMCRTG Field Service Technician will be contacting you to schedule this correction. In the event 206/208 alarms occur, you may silence the alarms intermittently using the audio pause button. If you have continued alarms, it is recommended to replace either the sensor box or the entire console if a secondary or backup console is available. Reference section 6.2 of the Instructions for Use (Part Number US-003-2019-08). For questions or concerns, please contact your local sales representative or FMCRTG Technical Support Services at 1-800-405-1321.
- Quantity
- 88 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124
- 510(k) numbers
- ["K191407"]
- PMA numbers
- not on file
- Product code
- QJZ
- Firm FEI
- 3001451489
- Firm city
- Waltham
- 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