Class 2 Device Recall Allura Xper FD and and Xper FD ORT

• Date Initiated by Firm: December 20, 2017
• Create Date: February 24, 2018
• Recall Status: Terminated on June 16, 2020
• Recall Number: Z-0717-2018
• Recall Event ID: 79091
• 510(K)Number: K141979
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Allura Xper FD and and Xper FD ORT - Philips X-ray Systems; ; Product Usage:; The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology. Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)
• Code Information: All Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes: 722001 722002 722003 722010 722026 722005 722011 722027 722006 722012 722028 722008 722013 722015 722023 722035 722020 722029 722038 722039 722058 722059
• Recalling Firm/ Manufacturer: Philips Electronics North America Corporation; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: R. Kathuria; 800-722-9377
• Manufacturer Reason for Recall: Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.
• FDA Determined Cause: Device Design
• Action: Philips sent an Urgent Field Safety Notice letter December 20, 2017 dated to all affected customers. The letter identified the affected product, problem and the actions to be taken. For question contact your local Philips representative.
• Quantity in Commerce: 1486
• Distribution: Worldwide Distribution - US Nationwide
• 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 and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.