[Recalled] Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system — Sedecal sent an email to its consignees to remind the users that the equipment… | FDA 2025-06-10

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in Spain and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from SEDECAL SA

• MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system — Class II
• Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system — Class II
• MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 — Class II
• Model Number 40KWFXPLUS.004, Mobile X-ray system — Class II
• Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system — Class II
• Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.