Company:Shape Medical Systems, Inc.
Date of Enforcement Report: 7/123/2014
Class lI:
PRODUCT
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system 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 patient assessment. Recall Number Z-2051-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Shape Medical Systems, Inc., St Paul, MN on 5/28/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
800
DISTRIBUTION
Nationwide
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