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Shape Medical Systems, Inc recalls Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Car
Recalled February 11, 2015 · FDA recall Z-1060-2015 · Shape Medical Systems
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. · FDA Class II
Units
564 devices
Sold at
Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
Description
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.
Product
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.
Manufacturer(s)
Shape Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →