Abbott Laboratories Inc. (St Jude Medical)

5 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment, Other Medical Devices

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.

Class I - Dangerous

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

May 5, 2021 Diagnostic Equipment Nationwide View Details →

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

Class I - Dangerous

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

May 5, 2021 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

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

May 5, 2021 Diagnostic Equipment Nationwide View Details →

NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

Class I - Dangerous

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.

Apr 22, 2021 Other Medical Devices View Details →

TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

Class I - Dangerous

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 lead to intermittent contact force data to be displayed during the procedure.

Apr 5, 2019 Other Medical Devices View Details →