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U.S. Department of Health and Human Services

Class 2 Device Recall CombiDiagnost R90

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  Class 2 Device Recall CombiDiagnost R90 see related information
Date Initiated by Firm October 21, 2021
Date Posted April 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-1355-2023
Recall Event ID 91853
510(K)Number K163210  K203087  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Code Information GTIN: (01)00884838076747 (Model 709030), (01)00884838101456 (Model 709031; Serial Numbers: 10000000 10000001 10000002 10000003 10000004 10000006 10000007 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000019 10000020 10000021 10000022 10000023 10000024 10000025 10000026 10000027 10000029 10000030 10000031 10000032 10000034 10000035 10000036 10000037 10000038 10000040 10000041 10000042 10000043 10000044 10000045 10000046 10000047 10000048 10000049 10000050 10000051 10000052 10000053 10000054 10000055 10000056 10000057 10000058 10000060 10000061 10000063 10000064 10000065 10000066 10000067 10000068 10000069 10000070 10000071 10000072 10000073 10000075 10000076 10000078 10000079 10000080 10000081 10000082 10000083 10000087 10000089 10000090 10000092 10000093 10000094 10000095 10000096 10000097 10000099 10000100 10000102 10000103 10000104 10000107 10000108 10000109 10000111 10000112 10000114 10000115 10000116 10000117 10000118 10000119 10000121 10000122 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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 2		 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 512 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 and Original Applicant = Philips Medical Systems DMC GmbH
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