FDA Device Recall Z-1884-2024: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1884-2024.

Recall Res Number

Z-1884-2024

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-04-11

Date Posted

2024-05-22

Date Terminated

N/A

Product Code

IYN

Event Number

94441

Product Quantity

418 units

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

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 Details 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.

Distribution Pattern US Nationwide distribution.

Code Information / Serial Numbers UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)

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Medical Device Recall: Z-1884-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer