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.
- Company
- Draegar Medical Systems, Inc.
- Recall Initiated
- February 8, 2019
- Recall Number
- Z-0974-2019
- Quantity
- 10699 in total
- Firm Location
- Andover, MA
Reason for Recall
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.
Distribution
US Nationwide distribution including Puerto Rico.
Lot / Code Info
All software versions, all serial numbers.
Root Cause
Software design
Action Taken
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 released for distribution. If you are aware of any incidents related to this issue or if you have any further questions regarding operation of your patient monitor, please contact Drager Service Technical Support between the hours of 8:00 AM- 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2 again).