FDAFDA · Food and drugs·Recall number 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.
Published March 13, 2019 · Recall initiated: February 8, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draegar Medical Systems, Inc.
- Distributor
- US Nationwide distribution including Puerto Rico.
- Lot
- All software versions, all serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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