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Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Recalled January 31, 2018 · FDA recall Z-0403-2018 · Philips Medical Systems (Cleveland)
Hazard
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. · FDA Class II
Units
559 total
Sold at
Worldwide distribution, including US nationwide.
Description
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.
Product
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →