Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia De
FDA device recall Z-1696-2025 · posted 2025-04-29 · Open, Classified
Recall details
- Recalling firm
- Spectrum Medical Ltd.
- Reason for recall
- Medical device software marketed without FDA clearance .
- Action taken
- On March 19, 2025 Spectrum Medical Inc. issued a "Urgent Medical Device Notification" to affected consignees via E-Mail. Spectrum Medical asked consignees to take the following actions: 1. Identify all users of these apps in your facility. 2. Conduct a risk assessment to determine if continued use of these apps is appropriate for your facility 3. Share this notice with all affected parties. 4. Complete the attached response form and return it to us at regulatory@spectrummedical.com.
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- MWI
- Quantity affected
- 78 systems
- Distribution
- California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Mi
- Date initiated
- 2025-03-19
- Date posted
- 2025-04-29
- Location
- Gloucester, United Kingdom
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