Siemens Medical Solutions USA, Inc recalls ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- Recall date
- July 29, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3190-2018
- FDA classification
- Class II
- Brand / firm
- Siemens Medical Solutions USA, Inc
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
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