LivaNova recalls S5 systems with incorrect manufacturing date labels. Some devices show dates in yy-mm-dd format instead of yyyy-mm-dd. Affected units may have labeling errors that could cause confusion during use.
Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
LivaNova is recalling certain S5 systems due to incorrect labeling on the manufacturing date. This error could lead to confusion about when the device was made, potentially affecting proper use during medical procedures.
The labeling error shows the manufacturing date in a short format (yy-mm-dd) instead of the full format (yyyy-mm-dd). This could cause confusion about the device's age, potentially leading to incorrect assumptions about its suitability for use during medical procedures.
Medical professionals using the S5 system for extracorporeal blood circulation procedures are most at risk. Patients receiving this treatment may be affected if the labeling error causes misinterpretation of the device's age.
Check for the model SORIN CONNECT DPIII KOMPL. S5 with serial numbers starting with 17BQC0247 to 17BQC0258. The device may have a manufacturing date label showing a two-digit year instead of four digits.
Look for the manufacturing date label on the device that shows a two-digit year (e.g., 2024) instead of four digits (e.g., 2024).
The incorrect date format (yy-mm-dd) could cause confusion about the device's age, potentially affecting medical procedures if the device is used beyond its intended time frame.
Check for the model SORIN CONNECT DPIII KOMPL. S5 with serial numbers starting with 17BQC0247 to 17BQC0258. The device may have a manufacturing date label showing a two-digit year instead of four digits.
The recall does not specify a remedy, so no action is required beyond checking the device labels for the date format error.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1119-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1119-2020 from LivaNova. 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.
