medical Class II Updated 2018-04-25

Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 with 4.1.7 XX026 software version model number

Recalled Product

Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories


Hazard / Issue

Surview scan with tube current lower than 30 mA is unable to be initialized.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
View official government recall

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