Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
FDA device recall Z-1884-2024 · posted 2024-05-22 · Open, Classified
Recall details
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- 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).
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IYN
- Quantity affected
- 418 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-04-11
- Date posted
- 2024-05-22
- Location
- Lexington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOBLUS™ Ultrasound Diagnostic System (K160559) | Hitachi Medical Corporation | 2016-10-18 |