| | Class 2 Device Recall Digisonics OBView Versions 4.8.2 SP6 4.8.3 |  |
| Date Initiated by Firm | June 26, 2023 |
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| Date Posted | July 20, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2214-2023 |
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| Recall Event ID |
92619 |
| 510(K)Number | K970402 |
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| Product Classification |
System, image processing, radiological - Product Code LLZ
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| Product | Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software |
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| Code Information |
UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3 |
| FEI Number |
1626313
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Recalling Firm/
Manufacturer |
Digisonics, Inc
305 Church At North Hills St
Raleigh NC 27609-2666
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| For Additional Information Contact |
713-529-7979 |
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Manufacturer Reason
for Recall | Software issue |
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FDA Determined
Cause 2 | Labeling design |
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| 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. |
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| Quantity in Commerce | 32 units |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = LLZ
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