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
FDA Recall Z-1396-2018 · Posted None
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-02-21
Date Terminated2020-04-10
Product Quantity291
Reason for Recall
Surview scan with tube current lower than 30 mA is unable to be initialized.
Firm Action
On February 21, 2018 Philips Medical Systems sent a Customer Information Letter regarding the Philips Brilliance 64 Software Model 4.1.7. Customers were informed of how to identify affected products and instructed to use the Instructions For Use recommended 30mA for surview scans. Customers with questions or concerns should contact their local Philips representative or local Philips Healthcare office Customer Care Solutions Center at 1-800- 722-9377.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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