Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiog

FDA device recall Z-1477-2023 · posted 2023-04-28 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking

Action taken

Philips issued a revised customer letter on 3/10/23 via U.S. mail -URGENT Medical Device Correction Notification Update CombiDiagnost R90 and ProxiDiagnost N90 Component damage due to short circuit & table stop due to broken tabletop cable. Customers received previous customer communications : 21 Oct 2021 for ProxiDiagnost N90 1.0 (706100); 17 Nov 2022 for ProxiDiagnost N90 1.1 (706110). Circulate this notice to all users of the device, attach the notice as an addendum to the IFU (User Manual). If a user observes fire in the M-cabinet, sees or smells smoke, or hears a popping noise coming from the M-cabinet, immediately remove power to the room, remove the patient, stop using the system for further examinations. Follow local fire regulations (e.g. evacuation, inform firefighters). 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. (FSE) will visit impacted customer sites to update the system with a hardware component to prevent the issue from occurring. If the table is not tilting or braking as expected: Bring the table back to 0degree position using the Tilting Switch, remove the patient from table, stop using the system for further examinations. Contact Customer Care Solutions Center (1-800-722-9377), reference FCO70600105 (ProxiDiagnost 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.

Root cause

Component design/selection

Status

Open, Classified

Product code

OWB

Quantity affected

Total Quantity: 234 units. US 195units. R.O.W 39 units

Distribution

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Chile, China, Germany, India, Italy, Malaysia, Netherlands, Panama, Spain, Thailand.

Date initiated

2022-10-21

Date posted

2023-04-28

Location

Cambridge, MA

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