FDAFDA · Food and drugs·Recall number Z-0254-2026
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Published October 29, 2025 · Recall initiated: June 10, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SEDECAL SA
- Distributor
- US: CA, IL, and NJ
- Lot
- UDI/DI 08436046001091, Serial Numbers: G23218
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Spain
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