Class 2 Device Recall UNIQ

• Date Initiated by Firm: June 11, 2018
• Create Date: July 25, 2018
• Recall Status: Terminated on July 03, 2024
• Recall Number: Z-2499-2018
• Recall Event ID: 80402
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.
• Code Information: UNIQ 1.0.10 UNIQ 1.0.10.5
• Recalling Firm/ Manufacturer: Philips Healthcare; 3000 Minuteman Rd; Andover MA 01810-1032
• Manufacturer Reason for Recall: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
• FDA Determined Cause: Software design
• Action: An Urgent Medical Device Correction letter dated June 11, 2018 was sent to customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers, until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor. Customer shall ensure that all staff with access to the affected systems are informed of the contents of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. For questions contact your local Philips representative Technical Support Line 1-800-722-9377.
• Quantity in Commerce: 459 affected systems
• Distribution: US 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.