Recall Z-2051-2014— Shape Medical Systems, Inc

Name: FDA recall Z-2051-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-28

Class II · Terminated

Class II FDA medical device recall by Shape Medical Systems, Inc, initiated 2014-05-28, terminated 2015-05-22. It names one FDA 510(k) clearance: K090722. 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.. 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: Shape Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-05-28
Terminated: 2015-05-22
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K090722 — SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEMShape Medical Systems, Inc.·cleared 2009-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.