Class 2 Device Recall ProxiDiagnost N90

• Date Initiated by Firm: December 15, 2023
• Date Posted: February 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1072-2024
• Recall Event ID: 93773
• 510(K)Number: K212837
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
• Code Information: UDI: (1) 00884838085619 (2) 00884838103221 UDI: (1) 00884838085619 (2) 00884838103221 Serial Numbers US: (1) 10001064 10001065 10001066 10001067 10001068 10001069 10001070 10001072 10001073 10001074 10001075 10001076 10001077 10001078 10001079 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001096 10001098 10001099 10001100 10001101 10001102 10001104 10001105 10001107 10001108 10001109 10001110 10001111 10001112 10001113 10001114 10001116 10001117 10001120 10001121 10001125 10001128 10001129 10001130 10001132 10001135 10001136 10001137 10001138 10001139 10001140 10001141 10001142 10001143 10001144 10001145 10001149 10001150 10001152 10001153 10001157 10001158 10001159 10001160 10001161 1000116 (2) 20000026 20000061 20000062 20000068 20000078 20000079 20000086 SN10001002 SN10001003 SN10001004 SN18000002 SN18000006 SN18000013 SN18000018 SN18000024 SN19000007 SN19000017 Serial Numbers OUS: Serial Number 10000042 SN10001000 SN10001006 10001055 10001071 10001082 10001083 10001094 10001095 10001103 10001106 10001118 10001119 10001123 10001133 10001134 10001155. ***ADDED TO SCOPE 20 Nov 2024*** 1) SN18000003 SN18000017 SN18000022 SN19000005 2) Serial Number 10001147 10001115 10001156 (Germany) 10001166 10001167 10001168 10001173 10001174 10001175 10001176 10001177 10001180 10001201 10001204 10001206. REMOVED 20 Nov 2024. REF:706110 S/N: 10001055 10001071 10001082 10001083 10001094
• Recalling Firm/ Manufacturer: Philips North America; 222 Jacobs St; Cambridge MA 02141-2296
• For Additional Information Contact: Customer Care Solution Center; 800-722-9377
• Manufacturer Reason for Recall: Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)
• FDA Determined Cause: Software design
• Action: ***UPDATE*** 19 ProxiDiagnost N90 Systems (18 US & 1 OUS) added to scope as these systems were produced prior to implementation of the solution in forward production. The newly identified consignees notified on 20 Nov 2024*** Philips issued URGENT Medical Device Correction ProxiDiagnost N90 1.1 and ProxiDiagnost Upgrade on 12/15/2024. Letter states reason for recall, health risk and action to take: For Issues 1 and 2: " To avoid previous patient data from being represented as current patient data, ensure all images have been exported from the previous RAD exam before starting a new examination. " Correct images will be square shape and wrong images can be recognized by a different patient anatomy and rectangular shape. If you identify a wrong image, flag the incorrect images and only export not flagged images for the current examination to PACS (See figure. Refer to Appendix A for specific details regarding the other issue descriptions and advice on actions to be taken. " Customers can continue using affected systems in accordance with the intended use. " Circulate this notice to all users of this device so that they are aware of the issue. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction Notice, understanding of the issue, and required actions to be taken. A Field Service Engineer (FSE) will contact you to schedule a time to visit your site and install the software upgrade to resolve the issues (Reference FCO70600110). Philips plans to start implementing the solution in Q2 2024. The software upgrade will also include software enhancements to improve clinical experience. 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).
• Quantity in Commerce: 151 units; 138 units US; 13 units OUS
• Distribution: Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
• 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