Reported Oct 29, 2025 · Ongoing
Model Number 40KW-FX.899, Mobile X-ray system
Sedecal Sa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEDECAL SA · Pelaya, 9 Pol. · Algete · N/A
Is this the product you have?
- Model Number 40KW-FX.899, Mobile X-ray system
- Lot codes and dates
- UDI/DI 08436046002166
- Serial NumbersG72770
- Amount recalled
- 1 unit
This recall covers 46 products
The agency filed one notice per product. You are reading one of them; the other 45 are below.
33 more are in the archive.
Where it was sold
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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