Sedecal SA recalls 56 mobile digital diagnostic X-ray systems distributed to facilities in California, Illinois and New Jersey. An email reminds users the equipment is not water-resistant and must be cleaned exactly as the manual prescribes. Stop using the device and follow the recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
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Sedecal mobile digital X-ray systems are used by healthcare facilities to perform portable radiographic imaging at the point of care. These units support diagnostics in wards, emergency rooms, and clinics.
The devices are not water-resistant and require strict cleaning per the manual. Inadequate cleaning or exposure to moisture could compromise device function or safety.
This recall is not part of a broader industry pattern.
Facilities may need to halt use of affected units and implement interim imaging options. The recall involves 56 units and service coordination with Sedecal SA.
Check the device label for model, UDI, and serial number plates. Manufacturer communications and the FDA recall page provide guidance.
Manufacturers typically offer a resolution within weeks to months, depending on stock and logistics.
Keep the recall notice, serial numbers list, purchase records, correspondence with Sedecal SA, and any replacement or refund documentation.
Model: SM-40HF-B-D-KM (AeroDR X30)\nUDI/DI: 08436046002593\nSerial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G81936, G86688, G82904, G86360, G84340, G86372, G81471\nDistribution: United States (CA, IL, NJ)\nQuantity recalled: 56 units\nManufacturer: Sedecal SA\nRecall date: 2025-06-10
No injuries or incidents have been reported.
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