Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- Sedecal
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 3 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Product type
- Mobile X-ray system
- Model numbers
- SM-40HF-B-D-C, UDI/DI 08436046001510, G37158, G61698, G62863, G41192, G62814, G41098 +4 more
- 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 Sedecal SM-40HF-B-D-C is a mobile X-ray system used in clinical settings to perform radiographic imaging at patient bedsides or in radiology departments.
Why This Is Dangerous
The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to unintended safety or functional issues as described by the manufacturer.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
10 units recalled in the United States (CA, IL, NJ). Healthcare facilities must cease use to ensure patient safety and to follow manufacturer guidance.
Practical Guidance
How to identify if yours is affected
- Verify model number SM-40HF-B-D-C on the device label.
- Confirm UDI/DI 08436046001510.
- Review cleaning procedures in the manual and ensure no water-based cleaning is used.
Where to find product info
Model number and serial numbers are on the device label; UDI/DI code is 08436046001510.
What timeline to expect
Not specified in the notice; follow Sedecal SA instructions for next steps.
If the manufacturer is unresponsive
- File a complaint with the FDA recalling agency if Sedecal SA is unresponsive.
- Document all communications with the manufacturer and healthcare facility management.
How to prevent similar issues
- When purchasing medical imaging devices, verify water-resistance and cleaning guidelines.
- Keep a copy of the recall notice and manuals on file.
- Establish a protocol for urgent recalls in hospital biosafety or biomedical engineering departments.
Documentation advice
Keep device labels, serial numbers, recall notices, and all correspondence with Sedecal SA and healthcare providers.
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Product Details
Model: SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system. Quantity: 10 units. Distribution: United States — CA, IL, NJ. Recall date: 2025-06-10. Status: ACTIVE. Brand: Sedecal SA.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C
- Distribution: CA, IL, NJ
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