Reported Nov 6, 2019 · Ongoing
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos.…
Draegar Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draegar Medical Systems, Inc. · 6 Tech Dr · Andover, MA · 01810-2434
Is this the product you have?
- The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
- Lot codes and dates
- Software version VG4.1.1/VG4.0.3 and lower
- Amount recalled
- 5634
Where it was sold
- Nationwide
Why it was recalled
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
This product could cause temporary or reversible health problems — stop using it.
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