FDA Medical Device Recalls (openFDA)
FUJIFILM Healthcare Americas Corporation: Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
- Recall number
- Z-1884-2024
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Product
- Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
- Status
- Open, Classified
- Initiated
- 2024-04-11
- Posted
- 2024-05-22
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)
- 510(k) numbers
- ["K160559"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1000513161
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28