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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity M300

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  Class 2 Device Recall Infinity M300 see related information
Date Initiated by Firm October 09, 2019
Create Date November 14, 2019
Recall Status1 Open3, Classified
Recall Number Z-0372-2020
Recall Event ID 84028
510(K)Number K130711  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Code Information All systems using Software version VG2.3.1 and lower
Recalling Firm/
Manufacturer		 Draegar Medical Systems, Inc.
6 Tech Dr
Andover MA 01810-2434
For Additional Information Contact Mike Kelhart
215-660-2349
Manufacturer Reason
for Recall		 The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Recall notification letter dated 10/9/19 was sent to customers. Recommended cybersecurity precautions: While we are in the process of updating the software, we recommend that you follow best recommended practices to limit access to the devices and wireless network: " Physical security of the patient monitors is recommended and is the responsibility of the operating organization. " Physical security boundaries to prevent access to your facility's network infrastructure is recommended and is the responsibility of the operating organization. " Drager relies on the medical device isolation mechanism of the VLANs and the proper configuration, implementation, and use of the operating organization's security measures to prevent the introduction of malware onto the Infinity Network. Action required: Please complete the attached Acknowledgement and Response Form and return it to Drager per instructions included on the form. The software upgrade will be provided free of charge. The upgrade path for your M300 device is dependent on the part number of your M300s currently in use. Your local Drager representative will contact you prior to the availability of software version VG2.3.2 to discuss the upgrade path. If you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM - 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Quantity in Commerce 12204
Distribution US nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MHX and Original Applicant = Draeger Medical Systems, Inc.
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