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U.S. Department of Health and Human Services

Class 2 Device Recall Shape Disposable Patient Interface

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  Class 2 Device Recall Shape Disposable Patient Interface see related information
Date Initiated by Firm December 23, 2014
Date Posted February 05, 2015
Recall Status1 Terminated 3 on April 14, 2015
Recall Number Z-1060-2015
Recall Event ID 70149
510(K)Number K090722  
Product Classification Calculator, predicted values, pulmonary function - Product Code BTY
Product Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001.
The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
Code Information Lot Numbers: 1412001, 1412002, 1412003 and 1412004
Recalling Firm/
Shape Medical Systems, Inc
5000 Township Pkwy
Saint Paul MN 55110-5852
For Additional Information Contact Technical Service
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
Action An Urgent Medical Device Recall letter was mailed to consignees on 12/23/2014. The letter identified affected product, described the issue and asked for product to be returned. Shape Technical Service will contact customers to assist in the return of product. A response form was asked to be returned. Customers with questions can call Shape Technical Service at 1-888-906-6266.
Quantity in Commerce 564 devices
Distribution Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
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