The FLUOROspeed is intended to be used as a universal diagnostic… — Class II medical device recall Z-0317-2025
Ongoing recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, reported 2024-11-13, distributed nationwide. X-ray R/F system software with certain versions of the control board may occasionally fail to display images w
| Recall number | Z-0317-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, Kyoto, N/A, Japan |
| Recall initiated | 2024-09-06 |
| Classified | 2024-11-07 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 30 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04540217065271 |
| Serial numbers | MQ493E3D2001, MQ493E3D2002, MQ493E3D2003, MQ493E3D4001, MQ493E3D4002, MQ493E3D4003, MQ493E3D4004, MQ493E3D4005, MQ493E3D5001, MQ493E3D5002, MQ493E3D6001, MQ493E3D6002, MQ493E3D6003, MQ493E3D7001, MQ493E3D7002, MQ493E3D8001, MQ493E3D8002, MQ493E3D9001, MQ493E3DA001, MQ493E3DA002, MQ493E3DB001, MQ493E3DB002, MQ493E3DC001, MQ493E3E1001, MQ493E3E1002 and 5 more |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.