Z-2337-2020 Class II Terminated
FDA device recall Z-2337-2020 was initiated by Philips North America, LLC on May 19, 2020 and is designated Class II. 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 … The recall status is terminated (terminated August 25, 2020). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 19, 2020
- Termination Date
- August 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
US Nationwide distribution including in the state of NJ.
Code Information
Serial Number USPP000004