Class 2 Device Recall ProxiDiagnost R90

• Date Initiated by Firm: October 21, 2021
• Date Posted: April 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1356-2023
• Recall Event ID: 91853
• 510(K)Number: K163210 K173433
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
• Code Information: GTIN: (01)00884838085619 (Model 706100), (01)00884838103221 (Model 709031); Serial Numbers: 597241 10000000 10000001 10000004 10000005 10000006 10000008 10000009 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000017 10000018 10000019 10000020 10000021 10000022 10000023 10000024 10000025 10000026 10000027 10000028 10000030 10000031 10000032 10000033 10000034 10000035 10000036 10000037 10000039 10000040 10000041 10000042 10000043 10000044 10000045 10000046 10000047 10000048 10000049 10000050 10000051 10000052 10000053 10000054 10000055 10001013 10001014 10001015 10001017 10001018 10001019 10001020 10001021 10001022 10001023 10001024 10001025 10001026 10001027 10001028 10001029 10001030 10001031 10001032 10001033 10001034 10001035 10001036 10001037 10001038 10001039 10001040 10001041 10001042 10001043 10001044 10001046 10001047 10001048 10001049 10001050 10001051 10001053 10001054 10001059 18000001 20000022 20000026 20000034 20000044 20000045 20000046 20000051 20000052 20000054 20000055 20000061 20000062 20000063 20000064 20000065 20000066 20000067 20000068 20000069 20000070 20000071 20000072 20000073 20000074 20000077 20000078 20000079 20000081 20000082 20000083 20000085 20000086 20000089 721815121706 SN10001000 SN10001001 SN10001002 SN10001003 SN10001004 SN10001005 SN10001006 SN10001007 SN10001008 SN10001009 SN10001010 SN10001011 SN10001012 SN18000001 SN18000002 SN18000003 SN18000004 SN18000005 SN18000006 SN18000007 SN18000008 SN18000009 SN18000011 SN18000012 SN18000013 SN18000014 SN18000015 SN18000016 SN18000017 SN18000018 SN18000019 SN18000020 SN18000021 SN18000022 SN18000023 SN18000024 SN18000152 SN18000249 SN19000001 SN19000002 SN19000003 SN19000004 SN19000005 SN19000006 SN19000007 SN19000008 SN19000009 SN19000010 SN19000011 SN19000012 SN19000013 SN19000014 SN19000015 SN19000016 SN19000017 SN19000018 10001057 10001064 10001059 10001058 10001062 10001069 10001052 10001060 10001070 10001061 10001063 10001068 10001067 10001066 10001073 10001065 10001103 10001075 10001079 10001085 10001084 10001074 10001106 10001087 10001088 10001076 10001086 10001093 10001091 10001089 10001100 10001099 10001104 10001078 10001098 10001102 10001105 10001072 10001096 10001090 10001077 10001118 10001109 10001110 10001107 10001112 10001092 10001111 10001113 10001101 10001116 10001108 10001045 10001055 10001083 10001095 10001094 10001071 10001082 10001080
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Customer Care Solution Center; 800-722-9377
• Manufacturer Reason for Recall: If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
• FDA Determined Cause: Device Design
• Action: An IMPORTANT PRODUCT NOTICE dated 10/21/21 was sent to customers with the CombiDiagnost R90 system. The system may experience a short circuit of the Electromagnetic Interference (EMI) filter or UA/UB board, with a potential for smoke and/or a popping sound coming from the Main cabinet. If a user sees or smells smoke or hears a popping noise coming from the M-cabinet, immediately remove power to the room (main circuit breaker) and remove the patient. Stop using the system for further examinations. An IMPORTANT PRODUCT NOTICE dated 10/21/21 was sent to customers with the ProxiDiagnost N90. Customers may encounter one or both issues: 1: Potential component damage due to short circuit, leading to smoke, or a popping noise coming from the M-cabinet. 2: Potential table stop due to a broken tabletop cable. An IMPORTANT PRODUCT NOTICE dated 11/15/22 was sent to customers with the ProxiDiagnost N90 1.1 for the same issues as the ProxiDiagnost N90 letter dated 10/21/21. An URGENT Medical Device Correction Notification Update for the CombiDiagnost R90 and ProxiDiagnost N90 dated February 2023 was sent to customers. For component damage due to short circuit, if a user observes fire in the M-cabinet, sees or smells smoke, or hears a popping noise coming from the M-cabinet: Contact Customer Care Solutions Center (1-800-722-9377). Reference FCO70900054 (CombiDiagnost R90), FCO70600105 (ProxiDiagnost N90 1.0), or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site. For ProxiDiagnost N90 table stop due to a broken tabletop cable, if the table is not tilting or braking as expected: Contact Customer Care Solutions Center (1-800-722-9377). Reference FCO70600105 (ProxiDiagnost N90 and N90 1.0) or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site to inspect and fix the cable. UPDATED 7/27/2023: Scope of affected products was increased. Additional consignees were notifie
• Quantity in Commerce: 243 units
• Distribution: US Nationwide. Global 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 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