Philips Electronics North America Corporation recalls Philips Healthcare Ingenuity CT Computed Tomography X-ray system
- Recall date
- April 14, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0408-2016
- FDA classification
- Class II
- Brand / firm
- Philips Electronics North America Corporation
- Sold / distributed
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indon…
Why it was recalled
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Philips Healthcare Ingenuity CT Computed Tomography X-ray system
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