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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Sedecal SA
- Product type
- Mobile X-ray System
- Model numbers
- UDI/DI unknown, Serial Numbers: 75723
- Sold at
- Unknown
- Where affected
- CA, IL, NJ
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 10, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
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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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recall number Z-0283-2026
- Serial Number to check: 75723
- Not water-resistant; cleaning per manual required
- Active recall as of 2025-06-10
- Affected states: CA, IL, NJ
- Stop use immediately to mitigate risk
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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