Abbott Laboratories v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System recall — FDA Z-1854-2021
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Overview of recall records associated with Abbott Laboratories Inc. (St Jude Medical), including dates, categories and classifications where available.
Classification mix: Class II: 5.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.
In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may…
This page summarizes recall records in which the official source identifies Abbott Laboratories Inc. (St Jude Medical) as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.