Philips North America, LLC recalls UroDiagnost Eleva, system code 708033
- Recall date
- December 30, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1492-2020
- FDA classification
- Class II
- Brand / firm
- Philips North America, LLC
- Sold / distributed
- Nationwide domestic distribution. Foreign distribution worldwide.
Why it was recalled
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
UroDiagnost Eleva, system code 708033
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