Recall Z-2337-2020— Philips North America, LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America, LLC, initiated 2020-05-19, terminated 2020-08-25. It names one FDA 510(k) clearance: K090483. 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: 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..
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-19
- Terminated
- 2020-08-25
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.