Z-1695-2025Class II

Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia...

Name: Z-1695-2025 Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia...
Creator: Spectrum Medical Ltd.
Published: 2025-03-19
License: https://open.fda.gov/license/

Spectrum Medical Inc / initiated 2025-03-19 / Open, Classified / root cause: software

FDA source

Spectrum Medical Ltd. began a recall of Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a... on 2025-03-19. FDA classified it as Class II and gives the reason as "Medical device software marketed without FDA clearance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1695-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-19
Posted: 2025-04-29
Recalling firm: Spectrum Medical Inc
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 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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Medical device software marketed without FDA clearance .
Root cause tag: software
FDA root cause: No Marketing Application
Action: 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 [email protected].
Quantity in commerce: 156 systems
Distribution: 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
Product codes and lots: All software revisions/No UDI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1695-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1695-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29
Z-1696-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29

Product code MWI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)