Siemens recalls Sensis and Sensis Vibe Hemo systems with software version VD12A due to potential CO measurement failure in cardiac procedures. Affected units have specific serial numbers and materials.
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.
Siemens is recalling certain Sensis and Sensis Vibe Hemo medical devices that have a software error in version VD12A. This error could cause the system to temporarily fail at measuring cardiac output using the thermodilution method during procedures, potentially affecting patient or operator safety.
The software error in version VD12A can cause the system to temporarily stop measuring cardiac output via thermodilution method during procedures. This could lead to inaccurate monitoring of blood flow, potentially impacting patient safety during critical medical interventions.
Healthcare professionals using Sensis, Sensis Vibe Hemo, or Sensis Vibe Combo systems with specific serial numbers and software version VD12A are most at risk. Patients undergoing cardiac procedures with these devices may be affected if the CO measurement fails.
Check for the product name (Sensis, Sensis Vibe Hemo, or Sensis Vibe Combo) with specific serial numbers listed in the recall notice. The affected units have material numbers 10764561, 11007641, or 11007642 and unique UDI codes.
Verify the software version on your device; affected units have version VD12A.
Check if your device's serial numbers match those listed in the recall notice (e.g., Sensis Vibe Hemo serial numbers 103137, 103144, etc.).
Software version VD12A in Sensis, Sensis Vibe Hemo, and Sensis Vibe Combo systems.
The system may temporarily stop measuring cardiac output using the thermodilution method, which could affect patient monitoring during procedures.
Check the serial numbers against the list provided in the recall notice, which includes specific numbers for Sensis, Sensis Vibe Hemo, and Sensis Vibe Combo models.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0499-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0499-2022 from Siemens. 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.
