FDA Device recall Z-2337-2020
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturati…
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturati… by Philips North America, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2337-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-19 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
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.
Identifiers
| code_info | Serial Number USPP000004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2337-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.