Class II — Potential Health Hazard

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

Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph Recalled by Philips North America, LLC Due to The labeling of the Philips Chest Pneumograph does...

Date: April 13, 2020
Company: Philips North America, LLC
Status: Terminated
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 Philips North America, LLC directly.

Affected Products

Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

Quantity: 2360 Units

Why Was This Recalled?

The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America, LLC

Philips North America, LLC has 88 total recalls tracked by RecallDetector.

Related Recalls

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