Company:Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report 1/31/2018
Class lI:
PRODUCT
Brilliance iCT – Model 728306 Computed Tomography X-ray systems
Recall Number Z-0403-2018
REASON
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., cleveland, OH on 7/11/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
559 total
DISTRIBUTION
Nationwide and Internationally
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