Shape Medical Systems, Inc recalls Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiop…

Recall date

December 23, 2014

Source

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

Recall number

Z-1060-2015

FDA classification

Class II

Brand / firm

Shape Medical Systems, Inc

Sold / distributed

Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.

Why it was recalled

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.

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

What was recalled

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.