Sedecal S.A. recalls Sedecal NOVA FA DR System. for diagnostic radiography.
- Recall date
- July 18, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0488-2019
- FDA classification
- Class II
- Brand / firm
- Sedecal S.A.
- Sold / distributed
- US and Canada
Why it was recalled
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sedecal NOVA FA DR System. for diagnostic radiography.
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