FDAFDA · Food and drugs·Recall number Z-0236-2015
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
Published December 24, 2014 · Recall initiated: July 31, 2014
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
It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- US Distribution
- Lot
- Software version 4.1.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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