Brand Name: Quantum Informatics — Class II medical device recall Z-1695-2025
Ongoing recall by Spectrum Medical Ltd., reported 2025-05-07, distributed in AL, AR, AZ, CA, CO, FL, GA, ID…. Medical device software marketed without FDA clearance .
| Recall number | Z-1695-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Medical Ltd., Gloucester, United Kingdom |
| Recall initiated | 2025-03-19 |
| Classified | 2025-04-29 |
| Reported by FDA | 2025-05-07 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | MX |
| Quantity | 156 systems |
| Reason classes | software |
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.
Reason for recall
Medical device software marketed without FDA clearance .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1695-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.