FDAClass IINovember 20, 2019

Infinity M300 telemetry monitoring device Software recall

Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

Why was Infinity M300 telemetry monitoring device Software recalled?

The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All systems using Software version VG2.3.1 and lower

Product
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Recalling firm
Draegar Medical Systems, Inc.
Quantity
12204
Distribution
US nationwide distribution.
Recall date
November 20, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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