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Open, Classified

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

FDA Recall Z-2214-2023 · Posted 2023-07-20

Recalling FirmDigisonics, Inc
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2023-06-26
Product Quantity32 units

Reason for Recall

Software issue

Firm 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.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970402DOCTORS REVIEW SYSTEMDigisonics, Inc. · 1997-03-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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