Z-1060-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2015
- Initiation Date
- December 23, 2014
- Termination Date
- April 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 564 devices
Product Description
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.
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.
Distribution Pattern
Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
Code Information
Lot Numbers: 1412001, 1412002, 1412003 and 1412004