GE Healthcare, LLC recalls GE Healthcare Lightspeed RT16 X-ray system
- Recall date
- May 19, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2189-2017
- FDA classification
- Class II
- Brand / firm
- GE Healthcare, LLC
- Sold / distributed
- Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New…
Why it was recalled
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GE Healthcare Lightspeed RT16 X-ray system
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