Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Reported: June 15, 2016 Initiated: September 6, 2015 #Z-1714-2016
Product Description
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Reason for Recall
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
Details
- Recalling Firm
- Philips Healthcare
- Units Affected
- US-423
- Distribution
- 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.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System. Recalled by Philips Healthcare. Units affected: US-423.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1714-2016.
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