SEDECAL recalls mobile X-ray system SM-40HF-B-D-C due to non-water resistance requiring strict cleaning. Affected units must follow manual instructions to prevent damage.
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 is recalling its mobile X-ray system model SM-40HF-B-D-C because it is not water-resistant. Improper cleaning could cause damage to the equipment. This recall affects units sold with specific serial numbers and model identifiers.
The mobile X-ray system is not water-resistant and requires strict cleaning according to the manual. Improper cleaning could lead to equipment damage but does not pose a direct safety risk to users.
Users of the SEDECAL mobile X-ray system model SM-40HF-B-D-C are affected. Healthcare facilities using this equipment are most at risk due to potential damage from improper cleaning.
Check for model number SM-40HF-B-D-C and serial numbers starting with G37587. This mobile X-ray system was sold with specific UDI/DI 08436046001510.
Review the equipment manual for proper cleaning procedures to avoid damage.
The recall does not indicate safety issues; it only requires strict cleaning to prevent damage.
Check for model number SM-40HF-B-D-C and serial numbers starting with G37587.
Follow the manual's cleaning instructions to avoid damage; no additional action is required beyond proper cleaning.
We’ve drafted a message you can send SEDECAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0269-2026 — SEDECAL SEDECAL Hello, I own a SEDECAL that is covered by recall Z-0269-2026 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.
