Recall Z-0694-2019— Philips Medical Systems Nederlands

Name: FDA recall Z-0694-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-03

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2018-12-03, terminated 2020-05-12. It names one FDA 510(k) clearance: K173356. Product: Ingenia Elition S, Ingenia Elition X. Reason: During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement..

Recalling firm: Philips Medical Systems Nederlands
Classification: Class II
Status: Terminated
Initiated: 2018-12-03
Terminated: 2020-05-12
Firm location: Best, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K173356 — Ingenia Elition S and Ingenia Elition X R5.4Philips Medical Systems Nederland B.V.·cleared 2018-03-06

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

Ingenia Elition S, Ingenia Elition X

Reason for recall

During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

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