FDAFDA · Food and drugs·Recall number Z-1714-2016
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Published June 15, 2016 · Recall initiated: September 6, 2015
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
Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare
- Distributor
- US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
- Lot
- Software v. 4.13, 4.14 and 4.15.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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