CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report

Quantum Informatics - Vision / Live Vue Monitor recalled

Spectrum Medical is recalling Quantum Informatics - Vision / Live Vue Monitor, Physiological, Patient (Without, distributed in 38 states. The recall was initiated on 19 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll software revisions/No UDI

Quantity recalled78 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1696-2025
FDA event ID: 96616
Recalling firm: Spectrum Medical, Gloucester
Classification: Class II
Status: Ongoing
Recall initiated: 19 Mar 2025
FDA classified: 29 Apr 2025
Reported: 7 May 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

19 Mar 2025	Recall initiated by company
29 Apr 2025	Classified by FDA	+41 days
7 May 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical device software marketed without FDA clearance .

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

Where it was distributed

California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Minnesota, Distric of Columbia, Ohio, Conneticut, New Jersey, Utah, North Carolina, Louisiana, Kentucky, New York, Kansas, South Carolina, Idaho, Tennessee, Oregon, Maine, Indiana, Oklahoma, New Mexico, North Dakota, Alabama, Michigan, Mississippi

Alabama Arkansas Arizona California Colorado Florida Georgia Idaho Illinois Indiana Kansas Kentucky Louisiana Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina

Questions about this recall

Why was it recalled?

Medical device software marketed without FDA clearance .

Which lots are affected?

All software revisions/No UDI

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96616

This product is part of a recall event; the main page for the event is Quantum Informatics - Viper Monitor, Physiological, Patient recalled.

Reported	Class	Recall	Company	Reason	Where
7 May 2025	CLASS II	Quantum Informatics - Viper Monitor, Physiological, Patient recalled	Spectrum Medical	Device Malfunction	38 states

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