Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems

Recalled April 25, 2018 · FDA recall Z-1396-2018 · Philips Medical Systems (Cleveland)

Hazard

Surview scan with tube current lower than 30 mA is unable to be initialized. · FDA Class II

Units

291

Sold at

Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland

Description

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

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

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →