Philips North America, LLC recalls Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the…

Recall date

April 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2245-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Magnetic Resonance Imaging Diagnostic 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.