Reported Jun 15, 2016 · Terminated
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Philips Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
- Lot codes and dates
Software v. 4.134.14 and 4.15
- Amount recalled
- US-423
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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