Philips North America, LLC recalls Cardiovascular Monitoring Device accessory - Product Usage:
Recalled Product
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.
Hazard / Issue
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Issued by
FDA
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