SEDEC: Mobile X-ray systems (model SM_40HF_B_D_VIR3) must be cleaned per manual to avoid damage. Recall covers specific serial numbers.
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.
SEDECAL's mobile X-ray system model SM_40HF_B_D_VIR3 is recalled because it is not water-resistant. Improper cleaning could cause damage to the equipment.
The equipment is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to damage or malfunction.
Users of the SEDECAL mobile X-ray system model SM_40HF_B_D_VIR3 with the listed serial numbers. Medical facilities using this equipment are most at risk.
Check for the model SM_40HF_B_D_VIR3 and serial numbers listed: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452.
Review the equipment's manual for proper cleaning procedures to avoid damage.
The equipment is not water-resistant and must be cleaned strictly according to the manual to prevent damage.
Model SM_40HF_B_D_VIR3 with serial numbers: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452.
No, but you must clean it strictly according to the manual to avoid damage.
We’ve drafted a message you can send SEDECAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0284-2026 — SEDECAL SEDECAL Hello, I own a SEDECAL that is covered by recall Z-0284-2026 from SEDECAL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.