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Recall Observatory FDA recall evidence

Device product

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

Z-1884-2024

April 11, 2024

Class II

Product summary

Firm
FUJIFILM Healthcare Americas Corporation
Event
Event 94441
Status
Ongoing
Classification
Class II
Quantity
418 units
Official record key
device-enforcement:Z-1884-2024

Official wording

Reason: 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).

Code information: UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).

Field note

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