Lower riskMedical device recall · FDA · Published April 5, 2019
St Jude Medical TactiSys Quartz Equipment Software 1.7.0: Log Data Storage Issue
St Jude Medical recalls TactiSys Quartz Equipment with software version 1.7.0 due to potential log data storage issues. Affected units may display incorrect contact force data during procedures.
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.
Take action
Contact the company
📍Recalling firmAbbott Laboratories Inc. (St Jude Medical)One St. Jude Medical Drive · Saint Paul, MN 55117
✎ GovInfoNow plain-language explainer
St Jude Medical is recalling TactiSys Quartz Equipment with software version 1.7.0 because it can fill disk space and prevent new log data storage. This may cause intermittent contact force data to be displayed during medical procedures, potentially affecting accuracy. Read more at govinfonow.com/recall/68490-st-jude-medical-tactisys-quartz-equipment-software-1-7-0.
“St Jude Medical TactiSys Quartz Equipment Software 1.7.0: Log Data Storage Issue.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68490-st-jude-medical-tactisys-quartz-equipment-software-1-7-0. Based on FDA recall #Z-1493-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2019%22&limit=1).
The FDA announced on April 5, 2019, that Abbott Laboratories Inc. (St Jude Medical) is recalling TactiSys Quartz Equipment with software version 1.7 because the device log may fill allocated disk space, preventing new data storage and potentially causing intermittent contact force data display issues during procedures.
How to tell if you have it
Brand: St Jude Medical
Product: TactiSys Quartz Equipment (with software version 1.7)
Model: PN-004 400
Part Numbers: 600043767, 100154367, 100154368
Units affected: 317
The hazard
According to the FDA, 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 being displayed during the procedure.
Context
GovInfoNow's records show Abbott Laboratories Inc. (St Jude Medical) has two other recalls on record since April 22, 2021. On May 5, 2021, the company recalled the St Jude Medical WorkMate Claris System v1.2 Upgrade Kit due to a software error that may cause screen blackout. On April 22, 2021, the St Jude Medical NeuroTherm NT2000iX RF Generator was recalled for potential capacitor failure.
How to tell if you have this one
Check for the model PN-004 400 with software version 1.7.0. Part numbers include 600043767 (China) and 100154367 (global). Serial numbers listed in the recall include many specific numbers.
Brand
St Jude Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your TactiSys Quartz Equipment; if it is 1.7.0, it is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall indicates a potential issue with data storage that could cause intermittent contact force data display, but it is not described as causing serious injury or death.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1493-2019 (April 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1493-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.