The Recall Desk

FDA (Devices) recall action 93855

FUJIFILM Healthcare Americas Corporation recalled 2 products on 2024-02-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-02-28
Critical
0
Units
21

Why these products were recalled

The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2024-02-28

    Synapse CV 6 Imaging Software Calculation Error May Cause Misdiagnosis

    FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.

    Product
    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-02-28

    Cardiology imaging software may calculate heart chamber size incorrectly

    Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.

    Product
    Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
    Category
    Distribution
    0 states