Recall Z-1884-2024— FUJIFILM Healthcare Americas Corporation

Name: FDA recall Z-1884-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-11

Class II · Ongoing

Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2024-04-11. It names one FDA 510(k) clearance: K160559. Product: Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24. 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)..

Recalling firm: FUJIFILM Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-04-11
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K160559 — NOBLUS Ultrasound Diagnostic SystemHitachi Medical Corporation·cleared 2016-10-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.