Philips SureSigns VM1SpO2 — Class II medical device recall Z-2337-2020
Terminated recall by Philips North America, LLC, reported 2020-06-17, distributed nationwide. Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not inten
| Recall number | Z-2337-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-05-19 |
| Classified | 2020-06-10 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2020-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Serial numbers | USPP000004 |
| Model numbers | 863266 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2337-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.