Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CARESCAPE PDM-Masimo SpO2. Physiological data monitor. Recalled by GE Healthcare, LLC Due to Masimo SpO2 Saturation Values can become frozen after...

Date: May 21, 2021
Company: GE Healthcare, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.

Affected Products

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Quantity: 111,728 units

Why Was This Recalled?

Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Healthcare, LLC

GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report