Recall – CT handheld stuck key

Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 7/31/2019
Class II

PRODUCT

BrightView SPECT, Model Number 882480

Recall Number: Z-2009-2019

REASON

An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.

RECALLING FIRM/MANUFACTURER

Philips Medical Systems (Cleveland) Inc. on 6/10/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
696

DISTRIBUTION

US Nationwide and International

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

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