Class 2 Device Recall CombiDiagnost R90

• Date Initiated by Firm: March 03, 2023
• Date Posted: May 15, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1589-2023
• Recall Event ID: 92333
• 510(K)Number: K203087
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: CombiDiagnost R90 R1.1
• Code Information: REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114
• Recalling Firm/ Manufacturer: Philips North America; 222 Jacobs St; Cambridge MA 02141-2296
• For Additional Information Contact: Dusty Leppert, CHP ; 978-482-2309
• Manufacturer Reason for Recall: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Philips sent an Electronic Product Radiation Correction letter dated March 3, 2023, to affected customers. The letter stated a Philips representative will contact affected customers to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect your system and apply the label if necessary. Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan approved by the Secretary of Health and Human Services. Customers were asked to complete and return the attached acknowledgement form to Philips DXR promptly upon receipt and no later than 30 days from receipt via email to: PD.CNR@philips.com. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: 1-800-722-9377 (Reference FCO70600112 for ProxiDiagnost N90 R.1.0 and FCO70900060 for CombiDiagnost R90 R.1.0 and R1.1).
• Quantity in Commerce: 25 systems in total
• 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 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 = JAA