LivaNova recalls Essenz HLM heart-lung machines with software version 1.5 due to touchscreen blackouts that may cause hypoxia. Affected units have specific serial numbers and were sold in Germany.
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
LivaNova is recalling heart-lung machines with software version 1.5 because brief touchscreen blackouts could lead to hypoxia (low oxygen) and hypoperfusion (inadequate blood flow). This is a serious risk during medical procedures.
The machine's touchscreen may briefly go dark for 10-15 seconds during operation, causing safety functions to reset. This can lead to temporary gas blender shutdowns and sensor deactivation, potentially causing low oxygen levels and inadequate blood flow if not corrected quickly.
Patients using the Essenz HLM heart-lung machine during surgery are most at risk. The recall affects specific units sold in Germany with serial numbers listed in the notice.
Check for the serial numbers listed in the recall notice (e.g., 49PK00436, 49PK00108). The software version is 1.5, and these units were sold in Germany.
Verify the software version is 1.5 by checking the machine's display or documentation.
Watch for brief touchscreen blackouts (10-15 seconds) that may require manual reactivation of gas blenders.
The touchscreen may go dark for 10-15 seconds, but safety functions remain operational. This can lead to temporary gas blender shutdowns and sensor deactivation, requiring manual reactivation.
Check for the specific serial numbers listed in the recall (e.g., 49PK00436) and software version 1.5. These units were sold in Germany.
The recall does not specify a fix; users must monitor for blackouts and manually reactivate gas blenders if needed.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0571-2025 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0571-2025 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.
