Draegar Infinity Delta Patient Monitors Recall: Cybersecurity Vulnerabilities Risk Device
Draegar Medical Systems recalls Infinity Delta Series patient monitors due to cybersecurity vulnerabilities that may cause device reboots, loss of function, and communication issues. Affected models include Delta, Delta XL, and Kappa monitors.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Draegar Medical Systems is recalling their Infinity Delta Series patient monitors (Delta, Delta XL, Kappa models) because of cybersecurity vulnerabilities that could cause the device to reboot, lose functionality, or lose communication with other systems. This risk affects patient monitoring safety in medical settings. Read more at govinfonow.com/recall/69022-draegar-infinity-delta-patient-monitors-recall-cybersecurity-vulnerabilities-risk-device.
Source Summary by GovInfoNow · govinfonow.com/recall/69022-draegar-infinity-delta-patient-monitors-recall-cybersecurity-vulnerabilities-risk-device · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0974-2019
Cite this page
“Draegar Infinity Delta Patient Monitors Recall: Cybersecurity Vulnerabilities Risk Device.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69022-draegar-infinity-delta-patient-monitors-recall-cybersecurity-vulnerabilities-risk-device. Based on FDA recall #Z-0974-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0974-2019%22&limit=1).
Why it’s dangerous
Cybersecurity vulnerabilities in the software could cause the patient monitors to unexpectedly reboot, lose functionality, or disconnect from other medical systems. This may disrupt critical patient monitoring and lead to potential safety risks during medical procedures.
Who’s affected
Healthcare providers using the Infinity Delta Series patient monitors for adult, pediatric, or neonatal patients are affected. The risk is highest for medical facilities that rely on these monitors for critical patient monitoring.
How to tell if you have this one
Check for the Infinity Delta Series monitors labeled Delta, Delta XL, or Kappa. These monitors are used in medical settings for adult, pediatric, and neonatal patients (excluding specific cardiac and respiratory parameters for neonates).
- Brand
Draegar Medical Systems- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution including Puerto Rico.
| Recall number | Product, codes & lots |
|---|---|
| Z-0974-2019 | 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.; All software versions, all serial numbers. |
| Z-0975-2019 | Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.; All software versions, all serial numbers. |
What to do — step by step
Check Device Status
Verify if the monitor is rebooting, losing functionality, or disconnecting from other systems.
Contact Manufacturer
Reach out to Draegar Medical Systems for guidance on next steps and potential software updates.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0974-2019 (February 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0974-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.