FDA Device recall Z-0974-2019
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatri…
- FDA Device
- Class II
- ongoing
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatri… by Draegar Medical Systems, citing the firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0974-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-08 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Draegar Medical Systems |
| Distribution | US |
Product
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.
Reason
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Identifiers
| code_info | All software versions, all serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0974-2019%22
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