Class 2 Device Recall Philips Allura Xper R9 and Azurion R1.1

• Date Initiated by Firm: August 18, 2017
• Date Posted: December 18, 2017
• Recall Status: Terminated on September 26, 2019
• Recall Number: Z-0255-2018
• Recall Event ID: 78739
• 510(K)Number: K162148
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
• Code Information: 7220063, 722064, 22065, 722066, 722078, 722079
• Recalling Firm/ Manufacturer: Philips Electronics North America Corporation; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Hugo Weusten; 800-722-9377
• Manufacturer Reason for Recall: When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination.
• FDA Determined Cause: Software design
• Action: Image Guided Therapy Systems ( IGT) sent an Urgent - Field Safety Notice Medical Device Correction letter dated August 11. 2017. The Downscale option should be disabled in all Export protocols until Philips corrects this issue. To accomplish this, you may refer to Chapter 13.8 (Configuring Export Protocols) of the system instructions for use that describes how to perform this action. You may also contact your Philips local representative for assistance in performing this action. All archived images exported using the downscale option would be affected by this issue, therefore such measurements from archived images should not be relied on. Additional precaution could be taken by re-performing measurements during the actual interventional procedure. The problem will be resolved by a software update, which is expected to be available by the end of 2017. In the interim, a similar notice will be provided along with newly manufactured devices shipped for use. For further questions, please call (800) 722-9377.
• Quantity in Commerce: 157
• Distribution: Worldwide Distribution - USA (nationwide) Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OWB