Recall Z-1715-2016— Philips Healthcare
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare, initiated 2015-09-06, terminated 2021-03-04. It names one FDA 510(k) clearance: K060937. Product: Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System. Reason: 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.
- Recalling firm
- Philips Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-06
- Terminated
- 2021-03-04
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips Healthcare Brilliance iCT SP 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.