Recall – Cardiac ablation system software version prevents storage of new data

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

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