The Recall Desk

FDA (Devices) recall action 78891

Fujifilm Medical Systems U.S.A., Inc. recalled 2 products on 2018-01-24

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
2018-01-24
Critical
0
Units
20

Why these products were recalled

There was a case that the swivel arm went down unintentionally when it was moved up/down.

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)··2018-01-24

    Fujifilm Aspire Cristalle Mammography Machine Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down unintentionally.

    Product
    ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for…
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    Distribution
    0 states
  • HighFDA (Devices)··2018-01-24

    Fujifilm Aspire HD Plus Mammography Machines Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.

    Product
    Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field…
    Category
    Distribution
    0 states