FDA recall Z-2337-2020

Philips North America, LLC · Class II · device

Product

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.

Distribution

US Nationwide distribution including in the state of NJ.

Key facts

Status
Terminated
Initiation date
2020-05-19
Report date
2020-06-17
Termination date
2020-08-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2337-2020