Monica Novii Wireless Patch System Recalled for Battery Damage and Heat
Monica Healthcare Ltd is recalling the Monica Novii Wireless Patch System due to potential battery damage and excess heat from prolonged charging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (excess heat and battery damage) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Monica Healthcare Ltd is recalling the Monica Novii Wireless Patch System, which includes the Novii Interface and Novii Pod. The Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity, and maternal heart rate using surface electrodes on the maternal abdomen. The Novii Interface allows the wireless output of the Novii Pod to be connected to a CTG Fetal monitor.
The recall is being issued because of potential battery damage and excess heat that can occur through prolonged charging. The source text does not specify the number of units affected, the specific distribution scope, or any reported injuries or illnesses.
Consumers should stop using the affected devices immediately. The source text does not provide specific instructions for consumers on how to return the product or obtain a refund, but the recall notice indicates that the product was distributed through the United States.
The recalled product
- Product
- Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables…
- Manufacturer
- MONICA HEALTHCARE LTD
- Category
- Medical Device — Fetal Monitor
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)
- See attached consignee list for affected device serial numbers.
Distribution
Distribution scope not specified by the agency.
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