Philips North America, LLC recalls Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that meas…

Recall date

May 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2337-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

US Nationwide distribution including in the state of NJ.

Why it was recalled

Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.