CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

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.

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