PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 17, 2020 Initiated: May 19, 2020 #Z-2337-2020

Product Description

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.

Reason for Recall

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.

Details

Units Affected
1
Distribution
US Nationwide distribution including in the state of NJ.
Location
Andover, MA

Frequently Asked Questions

What product 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.. Recalled by Philips North America, LLC. Units affected: 1.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2337-2020.