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Terminated

VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

FDA Recall Z-1145-2020 · Posted 2020-02-10

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeOWB
Date Initiated2019-12-23
Date Terminated2022-11-17
Product Quantity443

Reason for Recall

Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

Firm Action

On 12/23/2019, the firm sent medical device correction letters to affected customers via certified mail. The firm will be contacting customers with affected systems. The firm will be implementing software updates in all affected systems to correct the issue which was made available by the end of December 2019. The user was asked to do the following: -Please suspend the use of Digital Subtraction Angiography images for the verification of the registration during the Live Guidance step. -Please ensure that all staff working with the VesselNavigator application are informed of the recall. If you need further information or support concerning this issue, please contact your local Philips representative or call Technical Support Line at 1-800-722-9377.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution. US nationwide, Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Latvia, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181830Azurion R2.0Philips Medical Systems Nederland B.V. · 2018-08-02K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017-11-22K162148Allura Xper R9Philips Medical Systems Nethrlands BV · 2016-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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