Class 2 Device Recall Continuous CT Fluoroscopy DVI Ceiling Mount

• Date Initiated by Firm: May 01, 2021
• Create Date: November 24, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0277-2022
• Recall Event ID: 89039
• 510(K)Number: K001088
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
• Code Information: Serial Number: 3202
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer Reason for Recall: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part
• FDA Determined Cause: Device Design
• Action: Philips notified U.S. consignees by "URGENT - Field Safety Notice Medical Device Correction" FSN 72800751 for CT consignees and FSN 88200530 for PET/CT consignees via USPS Certified mail on 5/1/21. Non-U.S. customers will receive the letter through Philips Global Markets following local regulations. Letter states reason for recall, health risk and action to take: Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm. " Inspect the joint area of your CCT DVI Ceiling Mount Arm (the circled area in picture at the right) and observe that the safety clip is installed (as depicted in pictures below). " When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm. When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions: ¿ stop using the suspension monitor clinically ¿ move the monitor arm away from any person ¿ call Philips Service for repairs. Please acknowledge the receipt of this notice by completing, signing, and returning the form to the indicated email address: CTNM.QARA@Philips.com. Philips is inspecting the affected units and, if necessary, repairing joint safety components and joint wear components by FCO 72800751 and FCO 72800752 for CT consignees, and FCO 88200530 and FCO 88200531 for AMI consignees, respectively. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
• Quantity in Commerce: 1 unit
• Distribution: US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.