FDA
TactiSys Quartz Equipment (with software version 1.7)
Model: PN-004 400
Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
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.
The recall notice, and clinician acknowledgment form were hand delivered by Abbott Sales Representatives to all impacted accounts starting April 5, 2019. Completed Clinician Acknowledgement Forms, signify they received the correction notification for the impacted TactiSys Quartz Equipment with software version 1.7.