Z-2051-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2014
- Initiation Date
- May 28, 2014
- Termination Date
- May 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
DPIs with Lot Number 1405006 and higher.