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.
FDA Recall Z-1060-2015 · Posted 2015-02-05
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Recalling FirmShape Medical Systems, Inc
Recall StatusTerminated
Product CodeBTY
Date Initiated2014-12-23
Date Terminated2015-04-14
Product Quantity564 devices
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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