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

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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