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

FDA device recall Z-1355-2023 · posted 2023-04-10 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

JAA

Quantity affected

512 units

Distribution

US Nationwide. Global Distribution.

Date initiated

2021-10-21

Date posted

2023-04-10

Location

Cambridge, MA

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