Sedecal SA Recalls Shimadzu RF.004 Mobile X-ray System in 2025
Sedecal SA is recalling the Shimadzu RF.004 Mobile X-ray System after warnings that the device is not water-resistant and must be cleaned strictly according to the manual. Hospitals in California, Illinois, and New Jersey are affected. Stop using the device and follow recall instructions.
Quick Facts at a Glance
Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
Sedecal SA
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
3 states
At-Risk Groups
GENERAL
Hazard Information
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
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About This Product
The Shimadzu RF.004 Mobile X-ray System is a portable imaging device used in clinical settings to perform radiographs. It is distributed by Sedecal SA in the U.S.
Why This Is Dangerous
Water exposure or improper cleaning can compromise device integrity and safety. The recall emphasizes strict adherence to cleaning instructions to prevent damage or malfunction.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals and clinics in CA, IL, and NJ must stop using affected units and follow manufacturer instructions, which may affect patient workflow and equipment availability.
Practical Guidance
How to identify if yours is affected
Review device serial number plate for 75723
Confirm model is Shimadzu RF.004 Mobile X-ray System
Cross-check with Sedecal SA recall notice and FDA page Z-0283-2026
Where to find product info
FDA enforcement report and recall notice at the linked recall page
What timeline to expect
Recall actions and replacements typically involve several weeks from notice to completion
If the manufacturer is unresponsive
Escalate to hospital risk management
File a complaint with FDA recall if manufacturer is unresponsive
Document all communications and steps taken
How to prevent similar issues
Strictly follow cleaning procedures in the manual
Train clinical staff on cleaning requirements to avoid improper cleaning
Verify device water exposure guidelines before any cleaning operation
Documentation advice
Keep the recall notice, serial number records, communications with Sedecal SA, and any replacement or service orders for records
Product Details
Brand: Sedecal SA. Product: Shimadzu RF.004 Mobile X-ray System. Models: UDI/DI unknown; Serial Numbers: 75723. Sold in the United States with distribution in CA, IL, and NJ. Recall date: 2025-06-10. Status: Active. Price: Unknown.
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