ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and
FDA device recall Z-2045-2015 · posted 2015-07-08 · Terminated
Recall details
- Recalling firm
- Volcano Corp
- 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.
- Action taken
- Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 227 total units - all models
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
- Date initiated
- 2013-09-23
- Date posted
- 2015-07-08
- Date terminated
- 2015-07-09
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM (K082229) | Volcano Corporation | 2008-10-08 |