Reported Oct 29, 2025 · Ongoing
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, 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?
MobileDiagnost wDR 2.2Model Number REF 9890-010-89522Mobile X-ray system
- Lot codes and dates
- UDI/DI 08436046002357
- Serial Numbers
1,198 of 1,198 codes
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
- Amount recalled
- 1198 units
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sedecal Sa recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.