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U.S. Department of Health and Human Services

Class 2 Device Recall Shape HF Cardiopulmonary System

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  Class 2 Device Recall Shape HF Cardiopulmonary System see related information
Date Initiated by Firm May 28, 2014
Date Posted July 14, 2014
Recall Status1 Terminated 3 on May 22, 2015
Recall Number Z-2051-2014
Recall Event ID 68581
510(K)Number K090722  
Product Classification Calculator, predicted values, pulmonary function - Product Code BTY
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.
Code Information DPIs with Lot Number 1405006 and higher. 
Recalling Firm/
Manufacturer		 Shape Medical Systems, Inc
5000 Township Pkwy
Saint Paul MN 55110-5852
For Additional Information Contact Technical Service
888-906-6266
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Shape Medical Systems sent an Urgent Medical Device Correction letter dated June 17, 2014, to all affected customers. Customers were informed that new orders of the Disposable Patient interface devices (DPI) will require a software upgrade for the Shape HF Cardiopulmonary Testing System prior to using the new DPIs. Impacted DPIs will be shipped with Instructions to conduct the software upgrade and Technical Service will contact customers shipped the impacted DPIs to confirm receipt and assist with the software upgrade. A Response Form was requested to be returned. Customers with questions were instructed to call Shape Technical Service at 1-888-906-6266 or 651-621-2990.
Quantity in Commerce 800
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTY and Original Applicant = SHAPE MEDICAL SYSTEMS, INC
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