Z-1884-2024Class II

Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Name: Z-1884-2024 Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2024-04-11
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2024-04-11 / Open, Classified / root cause: design

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 on 2024-04-11. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1884-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-11
Posted: 2024-05-22
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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).
Root cause tag: design
FDA 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 [email protected], if you have any further questions regarding this field action.
Quantity in commerce: 418 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1884-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1884-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-22

Product code IYN

K160559Class IINOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation / cleared 2016-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)