SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: Device Recall

Recall Details

Recall Number

Z-0317-2025

Classification

Class II

Product Type

Device

Recalling Firm

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Status

Ongoing

Date Initiated

09/06/2024

Location

Kyoto, N/A, Japan

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

30

Reason for Recall

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.

Product Description

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 emergency treatment on an outpatient basis, as well as for bedside examinations.

Distribution Pattern

US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.

Other Recalls by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

• Class II: Risk 10/16/2025
  Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
• Class II: Risk 09/06/2024
  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.
• Class II: Risk 09/06/2024
  If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

View all recalls by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION →