Medical device recalls High risk

Spectrum Medical Ltd. recalls Quantum Pump Console

Recall date
May 29, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2238-2019
FDA classification
Class I
Brand / firm
Spectrum Medical Ltd.
Sold / distributed
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.

Why it was recalled

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Quantum Pump Console

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