FDA-Device2015-02-11Class II
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.
Shape Medical Systems, Inc
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.
Sold states
Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
Affected count
564 devices
Manufactured in
5000 Township Pkwy, N/A, Saint Paul, MN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1060-2015Don't want to check this manually?
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