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Shape Medical Systems Recalls
2 recalls on record · July 23, 2014 to February 11, 2015 · Medical Devices
Recalls by year
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 11, 2015Medical DevicesFDA
Shape Medical Systems, Inc recalls Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Car
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.
July 23, 2014Medical DevicesFDA
Shape Medical Systems, Inc recalls Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (
Hazard: Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.