Noblus AC Adapter for Ultrasound System Recalled for Smoke Hazard
FUJIFILM is recalling Noblus AC Adapters nationwide due to fire and smoke hazard. The adapters can overheat and generate smoke when the power cable is repeatedly inserted and removed.
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: FDA Class II medical device recall for potential fire hazard through overheating and smoke generation when power cable is repeatedly inserted and removed. The hazard is conditional rather than an actual reported occurrence, meeting criteria for High severity as a risk-of-harm product.
Plain-English summary
FUJIFILM Healthcare Americas Corporation is recalling the Noblus AC Adapter (Model AHM250PS24) used with the Noblus Ultrasound Imaging System. Approximately 418 units have been distributed nationwide, identified by UDI-DI (01) 04580292771704 with serial numbers before K17160001 (excluding K17160001).
The AC adapter can overheat and, in worst cases, generate smoke when excessive mechanical stress is applied to the power cable socket. This occurs primarily when the power cable is frequently inserted and removed.
The recalled adapter affects users of the Noblus Ultrasound Imaging System.
Consumers should immediately stop using the affected AC adapter and contact FUJIFILM Healthcare Americas Corporation for replacement instructions and corrective actions.
The recalled product
- Product
- Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Affected units
- 418
Distribution
Distributed nationwide across the United States.
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