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Recall Observatory FDA recall evidence

Device 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.

Z-1060-2015

December 23, 2014

Class II

Product summary

Firm
Shape Medical Systems, Inc
Event
Event 70149
Status
Terminated
Classification
Class II
Quantity
564 devices
Official record key
device-enforcement:Z-1060-2015

Official wording

Reason: 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.

Code information: Lot Numbers: 1412001, 1412002, 1412003 and 1412004

Distribution pattern: Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.