FDAFDA · Food and drugs·Recall number Z-2337-2020
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.
Published June 17, 2020 · Recall initiated: May 19, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- US Nationwide distribution including in the state of NJ.
- Lot
- Serial Number USPP000004
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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