Quantum Informatics recalls VISION/LIVE VUE patient monitoring software due to lack of FDA clearance. This software-only device may not be safe for use in operating rooms without regulatory approval.
Medical device software marketed without FDA clearance .
Quantum Informatics is recalling its VISION/LIVE VUE patient monitoring software because it was marketed without FDA clearance. This means the software might not be safe for use in operating rooms where patient safety is critical.
The software was sold without FDA approval, which means it hasn't been tested for safety and effectiveness. In operating rooms, this could lead to errors in patient monitoring that might cause harm.
Healthcare providers using this software in operating rooms are likely affected. Patients undergoing surgery with this unapproved software could be at risk.
The product is labeled as 'VISION / LIVE VUE' software-only patient monitoring. It was sold without FDA clearance and is used in operating rooms for patient safety.
Verify if your software has FDA clearance by checking the product documentation or contacting Quantum Informatics.
The recall record states the software was marketed without FDA clearance, so it may not be safe for use in operating rooms.
This software-only device is used in operating rooms for patient monitoring and was sold without FDA clearance.
The recall record does not specify a remedy, so contact Quantum Informatics for guidance.
We’ve drafted a message you can send Quantum Informatics to request your refund or repair — edit it as you like.
Subject: Recall Z-1696-2025 — Quantum Informatics Quantum Informatics Hello, I own a Quantum Informatics that is covered by recall Z-1696-2025 from Quantum Informatics. 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.
