# FDA recall Z-2337-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-05-19.

## 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.

## Distribution

US Nationwide distribution including in the state of  NJ.

## Key facts

- **Recall number:** Z-2337-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-19
- **Report date:** 2020-06-17
- **Termination date:** 2020-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2337-2020

## Citation

> AI Analytics. FDA recall Z-2337-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2337-2020. Source: US FDA. Licensed CC0.

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