Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Computed Tomography X-ray system
- Recall date
- April 13, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1695-2015
- FDA classification
- Class II
- Brand / firm
- Philips Medical Systems (Cleveland) Inc
- Sold / distributed
- Internationally to the countries of China and Norway.
Why it was recalled
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Brilliance iCT Computed Tomography X-ray system
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