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Recall Observatory FDA recall evidence

Device product

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

Z-1855-2021

May 05, 2021

Class II

Product summary

Firm
Abbott Laboratories Inc. (St Jude Medical)
Event
Event 87904
Status
Terminated
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-1855-2021

Official wording

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

Code information: None

Distribution pattern: US Nationwide distribution in the states of MI, KS, MO, TX.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error