Recall Z-1884-2024 · IYN System, Imaging, Pulsed Doppler, Ultrasonic
FUJIFILM Healthcare Americas Corporation
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
| Date | May 22, 2024 (initiated Apr 11, 2024) |
| Status | Open, Classified |
| 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). |
| Root cause | Device Design |
| 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 HCUSRegulatoryAffairs@fujifilm.com, if you have any further questions regarding this field action. |
| Quantity | 418 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160559 | NOBLUS Ultrasound Diagnostic System Hitachi Medical Corporation, Oct 18, 2016 |