Sedecal SA recalled 14 SM-40HF-B-D-C mobile X-ray systems distributed in California, Illinois and New Jersey after notifying consignees by email that the devices are not water-resistant. The company says cleaning must follow the manual strictly, warning about possible consequences of improper cleaning. Healthcare facilities and patients should stop using the devices immediately and follow the REMS
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.
Sedecal SM-40HF-B-D-C is a mobile X-ray unit rated at 40 kW intended for use in healthcare facilities.
The unit is not water-resistant. Cleaning must follow the manual to avoid adverse outcomes from improper cleaning.
This recall is not described as part of a broader industry pattern.
Immediate cessation of use to prevent potential damage or safety events; no injuries reported in the recall documentation.
Label on the equipment and the operator's manual; FDA recall page linked in recall notice
Manufacturer-led remediation timelines typically range 4-8 weeks for refunds or replacements.
Keep the recall notice, all emails, serial numbers, model numbers, and any correspondence with Sedecal SA for records.
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system. Distribution: 14 units in US (CA, IL, NJ). Sold in the United States. Price: Unknown.
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 SA recalled 5 SM-40HF-B-D-C Mobile X-ray systems distributed in California, Illinois and New Jersey after notifying consignees via email. The notice says the equipment is not water-resistant and must be cleaned strictly per the manual. Hospitals and clinics should stop using the devices immediately and follow the recall instructions.
Sedecal SA recalled 8 SM-32HF-B-D-C 32KW 50G Mobile X-ray systems sold in the US and Canada after notifying consignees by email that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice outlines possible consequences of improper cleaning. Hospitals should stop using the devices immediately and follow the recall instructions.
Sedecal SA recalls a single SM-20HF-Batt 20KW analog mobile X-ray system distributed in the United States and Canada after notifying consignees via email. The device is not water-resistant and must be cleaned strictly as described in the manual. Improper cleaning could cause safety or equipment issues.
Sedecal recalled 1 Mobile X-ray system due to major safety concerns. The device is not water-resistant and improper cleaning can cause malfunctions. Healthcare providers and patients must stop using the system immediately and follow manufacturer instructions.
SEDECAL SA recalled 1 unit of SM_40HF_BDC3 Mobile X-ray System distributed in California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly per the manual. Healthcare facilities should stop using the device immediately and follow the manufacturer’s recall instructions.
Sedecal SA recalled 1 unit of the SM_40HF_BDC Mobile X-ray System distributed in California, Illinois and New Jersey after notifying consignees that the unit is not water-resistant and must be cleaned strictly per the manual. The notice cites potential consequences of improper cleaning. Hospitals and providers should stop using the device and follow the manufacturer’s recall instructions.
SEDECAL SA recalled 268 units of the 40KWFXPLUS Mobile X-ray System distributed in California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly according to the manual. Healthcare facilities should stop using the device immediately and await further recall instructions.