Medical device recalls Moderate risk

Abbott Laboratories Inc. (St Jude Medical) recalls WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

Recall date
May 5, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1855-2021
FDA classification
Class II
Brand / firm
Abbott Laboratories Inc. (St Jude Medical)
Sold / distributed
US Nationwide distribution in the states of MI, KS, MO, TX.

Why it was recalled

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

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

What was recalled

WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

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