Spectrum Medical Ltd. recalls Quantum Informatics VIPER patient monitors with unapproved medical software. These software-only devices lack FDA clearance for patient safety monitoring, potentially failing to detect critical health issues during surgery.
Medical device software marketed without FDA clearance .
Spectrum Medical Ltd. is recalling Quantum Informatics VIP:ER patient monitors that use software without FDA approval. This means the devices might not properly detect critical health problems during surgery, putting patients at risk.
The software lacks FDA clearance, meaning it hasn't been proven safe or effective for patient monitoring. Without proper regulatory approval, the device might not detect critical health problems during surgery, potentially leading to adverse events.
Healthcare providers using these monitors in operating rooms are most at risk. Patients undergoing surgery could be affected if the device fails to detect critical health issues.
Check for the Quantum Informatics VIPER brand and product name. These monitors were sold as software-only devices for operating rooms without FDA clearance.
Verify if your monitor has FDA clearance for patient monitoring by checking the product documentation or contacting the manufacturer.
The official recall notice states the software lacks FDA clearance, so it is not approved for patient safety monitoring.
Look for the Quantum Informatics VIPER brand and product name. These monitors were sold as software-only devices for operating rooms without FDA clearance.
The recall notice does not specify a remedy, so contact Spectrum Medical Ltd. 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-1695-2025 — Quantum Informatics Quantum Informatics Hello, I own a Quantum Informatics that is covered by recall Z-1695-2025 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.
