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U.S. Department of Health and Human Services

Class 2 Device Recall NOBLUS" Ultrasound Diagnostic System

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 Class 2 Device Recall NOBLUS" Ultrasound Diagnostic Systemsee related information
Date Initiated by FirmApril 11, 2024
Date PostedMay 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1884-2024
Recall Event ID 94441
510(K)NumberK160559 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductNoblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Code Information UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)
FEI Number 1000513161
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactSAME
617-861-5300
Manufacturer 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).
FDA Determined
Cause 2		Device Design
ActionFujiFilm 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 in Commerce418 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYN
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