The Recall Desk

FDA (Devices) recall action 96616

Spectrum Medical Ltd. recalled 2 products on 2025-05-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-05-07
Critical
0
Units
234

Why these products were recalled

Medical device software marketed without FDA clearance .

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2025-05-07

    Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance

    Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.

    Product
    Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice soluti
    Category
    Distribution
    38 states
  • SevereFDA (Devices)··2025-05-07

    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.

    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 clini
    Category
    Distribution
    38 states