Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- Sedecal SA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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 08436046002166, G86476, G86632, G86634, G85447, G86619, G85453, G85461 +10 more
- Sold at
- Multiple Retailers
- 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 SM_40HF_B_D_VIR3 is described as a portable X-ray system used in medical facilities for bedside imaging.
Why This Is Dangerous
Not water-resistant. Cleaning must follow the manual. Improper cleaning may lead to adverse outcomes as outlined by the manufacturer.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics with these units should stop use and await further instructions. Service disruption may occur until the device is remediated.
Practical Guidance
How to identify if yours is affected
- Identify model SM_40HF_B_D_VIR3 and serial numbers listed above. Check the UDI 08436046002166.
- Compare your unit against the listed serials to determine exposure.
- Review the recall notice from FDA for Z-0284-2026.
Where to find product info
FDA enforcement page and Sedecal SA notice for recall details.
What timeline to expect
Remedy processing timelines are not provided in the data. Expect updates from Sedecal SA and the FDA.
If the manufacturer is unresponsive
- File a complaint with Sedecal SA, seek guidance from your healthcare provider, and contact the FDA for consumer questions.
- Consider legal counsel if there are injuries or unresponsive manufacturers.
How to prevent similar issues
- Follow the manual's cleaning instructions precisely.
- Avoid water exposure on this device.
- Verify any cleaning agents with the manufacturer before use.
- Document cleaning events and any communications.
Documentation advice
Keep recall notice, serial numbers, UDI, and all correspondence with Sedecal SA and healthcare providers.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model/UDI and serial numbers published
- Active recall status as of 2025-10-29
- Immediate action required: stop use and follow manufacturer instructions
- FDA recall reference: Z-0284-2026
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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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