Quantum Informatics VISION LIVE VUE Patient Monitor Recalled Without FDA Clearance
Spectrum Medical Ltd. is recalling the Quantum Informatics VISION / LIVE VUE patient monitoring software because it was marketed without required FDA clearance or approval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The device is classified as FDA Class II and was marketed without required FDA clearance. The product is a software-only medical device intended to monitor high-risk patients in operating rooms, making unauthorized marketing of such a device a serious compliance violation with potential patient safety implications.
Plain-English summary
Spectrum Medical Ltd. is recalling the Quantum Informatics VISION / LIVE VUE, a software-only patient monitoring device (SaMD) intended to provide near real-time patient safety and clinical monitoring solutions for high-risk patients in operating rooms. The device was marketed without FDA clearance or approval.
The VISION / LIVE VUE software integrates multiple information feeds to support remote monitoring of critical patient information and includes alerting systems and compliance tools. Approximately 78 systems have been distributed across multiple U.S. states and the District of Columbia.
Customers who have received this device should stop using it and contact Spectrum Medical Ltd. for further instructions regarding the recall.
The recalled product
- Product
- Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and…
- Manufacturer
- Spectrum Medical Ltd.
- Affected units
- 78
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All software revisions/No UDI
Distribution
Part of a larger recall action
This product is one of 2 recalled by Spectrum Medical Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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