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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum Informatics VIPER

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 Class 2 Device Recall Quantum Informatics VIPERsee related information
Date Initiated by FirmMarch 19, 2025
Date PostedApril 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1695-2025
Recall Event ID 96616
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductBrand 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 active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.
Code Information All software revisions/No UDI
FEI Number 3006073153
Recalling Firm/
Manufacturer		 Spectrum Medical Ltd.
Harrier 4, Meteor Business Park
Cheltenham Road East
Gloucester United Kingdom
For Additional Information ContactJeremy Tamari
800-2652331
Manufacturer Reason
for Recall		Medical device software marketed without FDA clearance .
FDA Determined
Cause 2		No Marketing Application
ActionOn 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.
Quantity in Commerce156 systems
DistributionCalifornia, 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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