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U.S. Department of Health and Human Services

Class 2 Device Recall Digisonics OBView Versions 4.8.2 SP6 4.8.3

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  Class 2 Device Recall Digisonics OBView Versions 4.8.2 SP6 4.8.3 see related information
Date Initiated by Firm June 26, 2023
Date Posted July 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2214-2023
Recall Event ID 92619
510(K)Number K970402  
Product Classification System, image processing, radiological - Product Code LLZ
Product Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Code Information UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
Recalling Firm/
Manufacturer		 Digisonics, Inc
305 Church At North Hills St
Raleigh NC 27609-2666
For Additional Information Contact
713-529-7979
Manufacturer Reason
for Recall		 Software issue
FDA Determined
Cause 2		 Labeling design
Action Intelerad/Digisonics issued an "Urgent Medical Device Recall" notice to its consignees by email on 06/26/2023. The notice explained the issue, the hazard, and provided the following information: 1. Digisonics advises all users to pay close attention to the FW% calculation and ensure that it is correct per the actual measurements, which are also displayed within the report. 2. Digisonics will install a warning so that the user is aware that there may be a discrepancy in the FW% displayed. The message will inform of a discordant result, inform the user of what was previously selected and what it is being changed to, and allow the user to proceed with the changes or revert back. Action Required from Client 1. Advise all users of the Digisonics OBView software of this issue. 2. When the patch update becomes available work with your CSM to have it installed. If you have any questions, call 713-529-7979.
Quantity in Commerce 32 units
Distribution US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY, UT, PA, MA, GA, VA, WA, WI, and Internationally to :Aruba
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 = LLZ and Original Applicant = DIGISONICS, INC.
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