Z-2045-2015 Class II Terminated
FDA device recall Z-2045-2015 was initiated by Volcano Corp on September 23, 2013 and is designated Class II. Reason for recall: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Fl… The recall status is terminated (terminated July 9, 2015). Affected quantity: 227 total units - all models.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2015
- Initiation Date
- September 23, 2013
- Termination Date
- July 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 227 total units - all models
Product Description
ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Reason for Recall
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
Code Information
Product/Part numbers: Combo Map - 802745-001. All software versions