Invivo recalls Xper Flex Cardio Physiomonitoring System units with specific serial numbers due to a potential issue where pressing ESC key accidentally closes Full Disclosure Control Window during playback.
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.
Invivo is recalling certain Xper Flex Cardio Physiomonitoring Systems that may close the Full Disclosure Control Window accidentally when pressing the ESC key during playback. This could lead to unintended data loss or system behavior changes.
While in Full Disclosure playback mode, pressing the ESC key instead of the X icon in the upper right corner can close the Full Disclosure Control Window. This may cause unintended data loss or system behavior changes during medical monitoring sessions.
Medical professionals using the Xper Flex Cardio Physiomonitoring System for heart and vascular disease monitoring are likely affected. Those with the specific serial numbers listed in the recall are at risk.
Check if your Xper Flex Cardio Physiomonitoring System has one of the listed serial numbers (US1203010251, US1239000027, etc.) from the recall notice.
Verify your device's serial number against the list of affected units provided in the recall notice.
The recall is due to a potential issue where pressing the ESC key during Full Disclosure playback accidentally closes the Full Disclosure Control Window instead of using the X icon in the upper right corner.
Check your device's serial number against the list of affected units provided in the recall notice. If affected, you may need to contact Invivo for further instructions.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Invivo to request your refund or repair — edit it as you like.
Subject: Recall Z-2115-2018 — Invivo Invivo Hello, I own a Invivo that is covered by recall Z-2115-2018 from Invivo. 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.
