Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/

FDA device recall Z-1822-2024 · posted 2024-05-15 · Open, Classified

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

QJZ

Quantity affected

88 units

Distribution

US Nationwide distribution.

Date initiated

2024-04-08

Date posted

2024-05-15

Location

Waltham, MA

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