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
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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/ Manufacturer |
Shape Medical Systems, Inc 5000 Township Pkwy Saint Paul MN 55110-5852
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For Additional Information Contact | Technical Service 888-906-6266 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = BTY
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