Recall Z-0974-2019 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
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 t
| Date | Feb 8, 2019 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On February 8, 2019, the firm, Drager, notified affected customers of the recall via an "Urgent: Medical Device Recall" letter. Customers were informed that the existing software had cybersecurity vulnerabilities and that software version VF10.1 would mitigate these issues. Customers were asked to complete a Customer Acknowledgment and Response Form and return it to Drager via fax 215-372-2940 or email to ditelford.guality@draeger.com. Your local Draeger Service representative will contact you to schedule an appointment for upgrading your systems software once a compatible version has been |
| Quantity | 10699 in total |
| Distribution | US Nationwide distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152407 | Infinity Delta, Infinity Delta XL, Infinity Kappa Draeger Medical Sytems, Inc., Sep 23, 2015 |