Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643

Recall date
July 9, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2344-2019
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY

Why it was recalled

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643

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