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U.S. Department of Health and Human Services

Class 2 Device Recall Delta, Delta XL, Kappa

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 Class 2 Device Recall Delta, Delta XL, Kappasee related information
Date Initiated by FirmFebruary 08, 2019
Create DateMarch 05, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0974-2019
Recall Event ID 82014
510(K)NumberK152407 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductInfinity 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.
Code Information All software versions, all serial numbers.
Recalling Firm/
Manufacturer		 Draegar Medical Systems, Inc.
6 Tech Dr
Andover MA 01810-2434
For Additional Information ContactTechnical Support
800-437-2437
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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).
Quantity in Commerce10699 in total
DistributionUS Nationwide distribution including Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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