Shape Medical Systems, Inc - Shape HF Cardiopulmonary System - Class 2 Recall

Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). The Shape-HF Cardiopulmonary Testing System is a cardiopulmonary gas exchange testing system intended for used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in their patient assessment. The Shape-HF Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts