Shimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure
Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay or cancellation of examinations rather than direct physical injury, fitting the criteria for a moderate severity issue.
Plain-English summary
Shimadzu Corporation Medical Systems Division is recalling 30 FLUOROspeed universal diagnostic imaging systems. These systems are used for radiographic and fluoroscopic studies, including general radiography/fluoroscopy, angiography, and pediatric examinations.
The recall is due to a software issue where certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode. This malfunction may lead to the possibility of delay or cancellation of the examination.
The affected units were distributed nationwide in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, and CO. Healthcare facilities should contact Shimadzu for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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