The Recall Desk

FDA (Devices) recall action 95450

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalled 2 products on 2024-11-13

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
2024-11-13
Critical
0
Units
33

Why these products were recalled

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

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

1–2 of 2

  • ModerateFDA (Devices)··2024-11-13

    Shimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure

    Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.

    Product
    The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emer
    Category
    Distribution
    21 states
  • ModerateFDA (Devices)··2024-11-13

    X-ray System Software May Fail to Display Images During Mode Switching

    SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.

    Product
    SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
    Category
    Distribution
    21 states