Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
FDA Recall Z-1884-2024 · Posted 2024-05-22
Recalling FirmFUJIFILM Healthcare Americas Corporation
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2024-04-11
Product Quantity418 units
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).
Firm Action
FujiFilm issued Urgent Medical Device Recall Letter via email on 4/11/24. Letter states reason for recall, health risk and action to take:
Please complete and return the Field Action Verification Form attached on page 3 of this communication.
Responding with the information requested is essential for ensuring appropriate action is taken.
Please accept the replacement of AC adapter that is implemented the countermeasure.
Please contact our field action coordinator, Kotei Aoki, via email at
[email protected], if you have any further questions regarding this field action.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.