Abbott Laboratories Inc. (St Jude Medical): Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

Agency Publication Date: June 14, 2021

Affected Products

Product: v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

Serial Numbers: 14399319, 15508962, 18782712, 18855856

Product: v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

Serial Numbers: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, 18917926

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

None

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87904

Status: Resolved

Manufacturer: Abbott Laboratories Inc. (St Jude Medical)

Manufactured In: United States

Units Affected: 3 products (4 units; 9 units; 8 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Serial Numbers: 14399319, 15508962, 18782712, 18855856

Serial Numbers: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, 18917926

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

None