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Recall Observatory FDA recall evidence

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

Z-0317-2025

September 06, 2024

Class II

Product summary

Firm
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Event
Event 95450
Status
Ongoing
Classification
Class II
Quantity
30
Official record key
device-enforcement:Z-0317-2025

Official wording

Reason: 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.

Code information: UDI-DI: 04540217065271. Serial Numbers: MQ493E3E3001, MQ493E3E3002, MQ493E3D6002, MQ493E3D5001, MQ493E3D8002, MQ493E3E1002, MQ493E3D4002, MQ493E3D6003, MQ493E3DA002, MQ493E3E2001, MQ493E3E2002, MQ493E3E1001, MQ493E3DC001, MQ493E3D9001, MQ493E3D4005, MQ493E3D7001, MQ493E3DB002, MQ493E3D2002, MQ493E3D4001, MQ493E3D7002, MQ493E3D4003, MQ493E3D4004, MQ493E3D2001, MQ493E3D8001, MQ493E3D5002, MQ493E3DB001, MQ493E3D2003, MQ493E3DA001, MQ493E3D6001, MQ493E3E1003

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software with certain versions of the control board may occasionally fail to