FDADecember 23, 2014device

Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.

What to do

FDA enforcement status: Terminated

Brands named

shape medical systemsshapeshape medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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