Sedecal SA recalled 3 units of the Mobile X-ray system 40KWFXPLUS.004 distributed in California, Illinois and New Jersey after warning users the device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could have consequences. Stop using the device and contact Sedecal SA or your healthcare provider for 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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Sedecal Mobile X-ray system is used in clinical settings for diagnostic imaging. It is designed for mobility within a facility.
Not being water-resistant and requiring strict cleaning per the manual can lead to unsafe conditions if cleaning is improper, potentially affecting device operation or patient safety.
This recall is not identified as part of a broader industry pattern in the provided data.
Limited to 3 units with specific distribution. Hospitals and clinics must verify model/serials and implement the recall instructions promptly to prevent potential safety issues.
FDA recall page and Sedecal SA communications; recall number Z-0248-2026
Refunds or replacements, if offered, typically take weeks to process
Keep the recall notice, serial numbers, model number, and all correspondence; document instances of non-compliance or issues during cleaning.
Model: 40KWFXPLUS.004. Serial numbers: G84489, G84504, G84589. Sold in the United States proximately in CA, IL, and NJ. Quantity: 3 units. Recall date: 2025-06-10. Report date: 2025-10-29. Status: ACTIVE. Brand: Sedecal SA. Category: Health & Personal Care / Medical Devices.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Sedecal recalled 8 units of the Easy Moving Plus mobile X-ray system distributed in California, Illinois and New Jersey. The devices are not water-resistant and cleaning must follow the manual to avoid the consequences of improper cleaning. Stop using the device and contact Sedecal SA or your healthcare provider for instructions.
Sedecal SA recalled 8 mobile X-ray units in the United States after notifying consignees that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice warns that improper cleaning could have consequences described in the manual. Healthcare providers and patients should stop using the devices immediately and contact Sedecal SA or their healthcare provider for the
Sedecal recalled 1,198 MobileDiagnost wDR 2.2 mobile X-ray systems distributed in California, Illinois and New Jersey. The company reminded users the equipment is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could have consequences outlined by Sedecal. Health care providers should stop using the device immediately and follow recall instructions.
Sedecal SA recalled 142 SM-40HF-B-D-C 40KW mobile X-ray systems sold to consignees in California, Illinois and New Jersey. Sedecal warned the units are not water-resistant and must be cleaned exactly as the manual prescribes, outlining the consequences of improper cleaning. Hospitals and clinics should stop using the devices immediately and follow the manufacturer's recall instructions.
Sedecal SA recalls 10 SM-40HF-B-D-C mobile X-ray systems distributed in California, Illinois and New Jersey. The recall stems from a warning that the equipment is not water-resistant and must be cleaned strictly according to the manual. Hospitals and providers should stop using the device immediately and contact Sedecal for instructions.
Sedecal SA recalls 181 SM-40HF-B-D-C mobile X-ray systems in 2025 after concerns about cleaning and water resistance. The device is not water-resistant and must be cleaned strictly according to the manual. Manufacturers warn of potential consequences if cleaning is not followed. Hospitals and clinics should stop using the device and follow recall instructions immediately.
Sedecal recalled 55 Mobile X-ray System units sold to facilities in California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned exactly as described in the manual, with clear warnings about the consequences of improper cleaning. Hospitals and healthcare providers should stop using the device immediately and follow Sedecal's recall instructions.
Sedecal SA recalled 3 units of the SM_40HF_B_D_VIR3.004 Mobile X-ray system distributed to consignees in California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned strictly per the manual. Patients and healthcare providers should stop using the device immediately and follow recall instructions.