VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper

FDA device recall Z-1145-2020 · posted 2020-02-10 · Terminated

Recall details

Recalling firm: Philips North America, LLC
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.
Action taken: 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
Status: Terminated
Product code: OWB
Quantity affected: 443
Distribution: Worldwide Distribution. US nationwide, Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Irel
Date initiated: 2019-12-23
Date posted: 2020-02-10
Date terminated: 2022-11-17
Location: Andover, MA

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Record	Firm	Date
Azurion R2.0 (K181830)	Philips Medical Systems Nederland B.V.	2018-08-02
Azurion series R1.2 (K172822)	Philips Medical Systems Nederland B.V.	2017-11-22
Allura Xper R9 (K162148)	Philips Medical Systems Nethrlands BV	2016-11-23