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Open, Classified

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.

FDA Recall Z-0974-2019 · Posted None

Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2019-02-08
Product Quantity10699 in total

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.

Firm 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 [email protected]. 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).

Root Cause

Software design

Distribution Pattern

US Nationwide distribution including Puerto Rico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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