Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
- Recall Initiated
- April 11, 2024
- Posted
- May 22, 2024
- Recall Number
- Z-1884-2024
- Quantity
- 418 units
- Firm Location
- Lexington, MA
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.
Lot / Code Info
UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)
Root Cause
Device Design
Action Taken
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 HCUSRegulatoryAffairs@fujifilm.com, if you have any further questions regarding this field action.