Spectrum Medical Ltd. is recalling approximately 234 systems of its Quantum Informatics VIPER and VISION / LIVE VUE patient monitoring software. These products were marketed and distributed to hospitals without the necessary FDA clearance. The software is used in operating rooms to provide real-time safety data for high-risk patients, but because it has not been reviewed by the FDA, its safety and effectiveness cannot be guaranteed.
The use of medical software that has not been cleared by the FDA could lead to errors in patient monitoring or data distribution, which may result in improper clinical decisions during surgery. While no injuries or incidents have been reported, the lack of regulatory review poses a potential risk to patient safety in high-stakes clinical environments.
Recall #: Z-1695-2025; Quantity: 156 systems; Affects all software revisions.
Recall #: Z-1696-2025; Quantity: 78 systems; Affects all software revisions.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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