FDAFDA · Food and drugs·Recall number Z-2223-2012
The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Published August 29, 2012 · Recall initiated: July 18, 2012
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
1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden
- Lot
- System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504 System Code # 728326, Serial #s: 300010, 300030, and 300018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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