Recall Z-2045-2015— Volcano Corp
Class II · Terminated
Class II FDA medical device recall by Volcano Corp, initiated 2013-09-23, terminated 2015-07-09. It names one FDA 510(k) clearance: K082229. Product: 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: 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..
- Recalling firm
- Volcano Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-23
- Terminated
- 2015-07-09
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's record- K082229 — S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.