The Infinity Acute Care System recall
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Why was The Infinity Acute Care System recalled?
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
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?
Software version VG4.1.1/VG4.0.3 and lower
- Product
- The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
- Recalling firm
- Draegar Medical Systems, Inc.
- Quantity
- 5634
- Distribution
- US Nationwide distribution.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)