Recall Z-1477-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America Llc
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
| Date | Apr 28, 2023 (initiated Oct 21, 2022) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Component design/selection |
| Action | 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 comin |
| Quantity | 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. |
| FDA record | Open on fda.gov |