Day

July 20, 2023
20
Jul

FDA Recall: Software Issue with Ultrasound Reporting

July 20, 2023
Company: Digisonics, Inc Date of Enforcement Report: 07/20/2023 Class II PRODUCT Digisonics OBView Versions 4.8.2 SP6 – 4.8.3, Ultrasound reporting software Recall Number: Z-2214-2023 REASON: Software issue RECALLING FIRM/MANUFACTURER: Digisonics, Inc VOLUME OF PRODUCT IN COMMERCE: 32 units DISTRIBUTION: US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY,...
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