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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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