Noblus AC Adapter used with the Noblus Ultrasound Imaging… recallZ-1884-2024 · FUJIFILM Healthcare Americas Corporation · initiated Apr 11, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FUJIFILM Healthcare Americas Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1884-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 11, 2024
- Posted by the FDA
- May 22, 2024
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 418 units
- Product code
- IYN
- FDA submissions
- K160559
- Distribution
- US Nationwide distribution.
Product description
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Code information (models, lots, serial numbers)
UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HITACHI NoblusHitachi, Ltd. · System, Imaging, Pulsed Echo, Ultrasonic1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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