Philips Healthcare Brilliance iCT Computed Tomography recall: Software Issue
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Why was Philips Healthcare Brilliance iCT Computed Tomography 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software v. 4.13, 4.14 and 4.15.
- Product
- Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
- Recalling firm
- Philips Healthcare
- Quantity
- 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.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)