FDA recall Z-1884-2024

FUJIFILM Healthcare Americas Corporation · Class II · device

Product

Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Reason for recall

AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-04-11
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1884-2024