Recall – Pressing and holding Stop button leads to restart of movement

Company: Philips Medical Systems Nederlands
Date of Enforcement Report: 1/8/2019
Class II

PRODUCT

Ingenia Elition S, Ingenia Elition X

Recall Number: Z-0694-2019

REASON

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

RECALLING FIRM/MANUFACTURER

Philips Medical Systems Nederlands, Best, Netherlands on 12/3/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
35

DISTRIBUTION
U.S. Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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