Quantum Informatics VIPER (Spectrum Medical) – FDA clearance (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced activ
Brand
Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom
Lot Codes / Batch Numbers
All software revisions/No UDI
Products Sold
All software revisions/No UDI
Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom is recalling Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhy due to Medical device software marketed without FDA clearance .. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medical device software marketed without FDA clearance .
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI
Page updated: Jan 10, 2026