The Recall Desk

FDA (Devices) recall action 86846

Shimadzu Medical Systems recalled 3 products on 2020-12-16

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-12-16
Critical
0
Units
52

Why these products were recalled

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

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.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2020-12-16

    Shimadzu MH-200S X-Ray System Recalled for Ceiling Arm Software Defect

    Shimadzu Medical Systems is recalling 22 MH-200S X-Ray systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2020-12-16

    Shimadzu Trinias Digital Angiography System Recalled for Ceiling Arm Software Issue

    Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and w
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2020-12-16

    Shimadzu Bransist Safire Digital Angiography System Recalled for Software Defect

    Shimadzu Medical Systems is recalling seven Bransist Safire Digital Angiography Systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm.

    Product
    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
    Category
    Distribution
    13 states