Company: Abbott Laboratories Inc. (St Jude Medical)
Date of Enforcement Report: 6/5/2019
Class II
PRODUCT
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Recall Number: Z-1493-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Inc. (St Jude Medical) on 4/5/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
317 units
DISTRIBUTION
US Nationwide and International