Z-0317-2025Class II

The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and...

Name: Z-0317-2025 The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and...
Creator: Shimadzu Corporation Medical Systems Division
Published: 2024-09-06
License: https://open.fda.gov/license/

Shimadzu Corporation Medical Systems Division / initiated 2024-09-06 / Open, Classified / root cause: software

FDA source

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION began a recall of The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can... on 2024-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0317-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-06
Posted: 2024-11-07
Recalling firm: Shimadzu Corporation Medical Systems Division
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: software
FDA root cause: Software change control
Action: On 9/13/24, recall notices were emailed to consignees asking them to do the following: 1) If the problem occurs it is possible to solve this problem by turning off the power of the system and then pushing the reset switch on the Digital radiography unit s control cabinet. 2) Your firm authorized service representative will be contacting to schedule the implementation of the corrective action but if you are not contacted, contact the firm's National Support. 3) Complete and return the response form via email to response to [email protected] If you have questions contact the firm's National Technical Support at 844-487-2767, available 8:00AM-5:00PM, Monday - Friday.
Quantity in commerce: 30
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0317-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0316-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07
Z-0317-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07

Product code JAA

K191877Class IIFLUOROspeedShimadzu Corporation / cleared 2019-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)