Recall Z-1477-2023— Philips North America Llc

Name: FDA recall Z-1477-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-21

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2022-10-21. It names 2 FDA 510(k) clearances: K212837, K173433. Product: Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system. 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.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2022-10-21
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K212837 — ProxiDiagnost N90Philips Medical Systems Dmc GmbH·cleared 2021-09-21
K173433 — ProxiDiagnost N90Philips Medical Systems Dmc GmbH·cleared 2018-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.