CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report

The FLUOROspeed is intended to be used as a universal recalled

Shimadzu Corporation Medical Systems Division is recalling The FLUOROspeed is intended to be used as a universal diagnostic imaging system for, distributed nationwide in the US. The recall was initiated on 6 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled30

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0317-2025
FDA event ID: 95450
Recalling firm: Shimadzu Corporation Medical Systems Division, Kyoto, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 6 Sep 2024
FDA classified: 7 Nov 2024
Reported: 13 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

6 Sep 2024	Recall initiated by company
7 Nov 2024	Classified by FDA	+62 days
13 Nov 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Colorado Connecticut Florida Hawaii Iowa Illinois Louisiana Massachusetts Maryland Minnesota Montana North Carolina Nebraska New York Ohio Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 95450

This product is part of a recall event; the main page for the event is Sonialvision G4 is a multi-purpose X-ray R/F system recalled.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024	CLASS II	Sonialvision G4 is a multi-purpose X-ray R/F system recalled	Shimadzu Corporation Medical Systems Division	Device Malfunction	Nationwide

More recalls from Shimadzu Corporation Medical Systems Division

All 6

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025Device	CLASS II	Ceiling Type X-Ray Tube Support recalled by Shimadzu Corporation Medical	Shimadzu Corporation Medical Systems Division	Device Malfunction	Nationwide
13 Nov 2024Device	CLASS II	Sonialvision G4 is a multi-purpose X-ray R/F system recalled	Shimadzu Corporation Medical Systems Division	Device Malfunction	Nationwide
30 Oct 2024Device	CLASS II	Trinias unity, Digital Angiography System with Catheterization Table recalled	Shimadzu Corporation Medical Systems Division	Other	Nationwide
20 Mar 2024Device	CLASS II	Shimadzu, Trinias, Digital Angiography System recalled	Shimadzu Corporation Medical Systems Division	Other	Nationwide
9 Aug 2023Device	CLASS II	Over-Head Ceiling Tube Support, CH-200, CH-200M, Used recalled	Shimadzu Corporation Medical Systems Division	Other	Nationwide

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