FDAFDA · Food and drugs·Recall number Z-1396-2018
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
Published April 25, 2018 · Recall initiated: February 21, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Surview scan with tube current lower than 30 mA is unable to be initialized.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
- Lot
- Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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