Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NOBLUS" Ultrasound Diagnostic System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall NOBLUS" Ultrasound Diagnostic System see related information
Date Initiated by Firm April 11, 2024
Date Posted May 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1884-2024
Recall Event ID 94441
510(K)Number K160559  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Noblus 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)
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact SAME
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
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 HCUSRegulatoryAffairs@fujifilm.com, if you have any further questions regarding this field action.
Quantity in Commerce 418 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYN and Original Applicant = HITACHI MEDICAL CORPORATION
-
-