Recall Z-1809-2020— Philips North America, LLC

Name: FDA recall Z-1809-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-03

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-03, terminated 2023-02-01. It names one FDA 510(k) clearance: K181830. Product: Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079. Reason: When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-03
Terminated: 2023-02-01
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K181830 — Azurion R2.0Philips Medical Systems Nederland B.V.·cleared 2018-08-02

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

Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079

Reason for recall

When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.

Data sourced from openFDA. This site is unofficial and independent of the FDA.