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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.