Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance
Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The device is classified as FDA Class II and was marketed without required clearance, representing a regulatory violation involving a high-risk patient monitoring system used in operating rooms where patient safety is critical. Although no reported illnesses or injuries are stated in the source, the regulatory failure and intended use in acute care settings justify a Severe rating.
Plain-English summary
Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a software-based physiological patient monitor intended for use in operating rooms. The device integrates multiple information feeds to provide near real-time patient safety information and clinical best practice solutions. VIPER was marketed and distributed without FDA clearance.
The software has been distributed to healthcare facilities in 39 states and the District of Columbia. The recall affects all software revisions of the product. Patients and healthcare providers who have used this device should contact Spectrum Medical Ltd. or consult with their healthcare facility regarding the status of their VIPER system and any necessary next steps.
The recalled product
- 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 soluti
- Manufacturer
- Spectrum Medical Ltd.
- Hazard
- unauthorized-marketing
- lack-of-fda-clearance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All software revisions/No UDI
Distribution
Distribution scope not specified by the agency.
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