FDAFDA · Food and drugs·Recall number Z-2051-2014
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.
Published July 23, 2014 · Recall initiated: May 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Shape Medical Systems, Inc
- Distributor
- Nationwide Distribution
- Lot
- DPIs with Lot Number 1405006 and higher.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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