Reported Nov 13, 2024 · Ongoing
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic…
Shimadzu Corporation Medical Systems Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Nishinokyo Kuwabara -Cho · Kyoto, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI04540217065271
- Serial Numbers
MQ493E3E3001MQ493E3E3002MQ493E3D6002MQ493E3D5001MQ493E3D8002MQ493E3E1002MQ493E3D4002MQ493E3D6003MQ493E3DA002MQ493E3E2001MQ493E3E2002MQ493E3E1001MQ493E3DC001MQ493E3D9001MQ493E3D4005MQ493E3D7001MQ493E3DB002MQ493E3D2002MQ493E3D4001MQ493E3D7002MQ493E3D4003MQ493E3D4004MQ493E3D2001MQ493E3D8001MQ493E3D5002MQ493E3DB001MQ493E3D2003MQ493E3DA001MQ493E3D6001MQ493E3E1003
- Amount recalled
- 30
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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