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.
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.
The software version 1.7.0 fills the allocated disk space, preventing new log data from being stored. This can cause intermittent contact force data to be displayed during procedures, which might lead to inaccurate measurements.
Medical professionals using the TactiSys Quartz Equipment with software version 1.7.0 are likely affected. Patients undergoing procedures with this equipment may be at risk if data accuracy is compromised.
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.
Verify the software version on your TactiSys Quartz Equipment; if it is 1.7.0, it is affected.
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.
Check for the model PN-004 400 with software version 1.7.0. Part numbers include 600043767 (China) and 100154367 (global).
The recall does not specify a remedy, so users should check the software version and contact St Jude Medical if they have version 1.7.0.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1493-2019 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-1493-2019 from St Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
