Reported Feb 11, 2015 · Terminated
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF…
Shape Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shape Medical Systems, Inc · 5000 Township Pkwy · Saint Paul, MN · 55110-5852
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
141200114120021412003 and 1412004
- Lot Numbers
- Amount recalled
- 564 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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