FDA-Device2021-06-23Class II

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

Abbott Laboratories Inc. (St Jude Medical)
Hazard

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

Sold states
US Nationwide distribution in the states of MI, KS, MO, TX.
Affected count
8 units
Manufactured in
1 Saint Jude Medical Dr, Saint Paul, MN, United States
Products
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1855-2021

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