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 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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The Sedecal 40KWFX Mobile X-ray System is a portable medical imaging device used in clinical settings to perform radiographic exams at patient bedsides or exam rooms. Hospitals purchase these systems for rapid diagnostics and reduced patient transport.
The device is not water-resistant. Cleaning must follow the manual exactly to prevent adverse outcomes. Improper cleaning could compromise device function or patient safety.
This recall is not described as part of a broader industry pattern. No mass incidents are reported in the data.
Healthcare facilities must halt use of affected units, verify serial numbers, and coordinate with Sedecal for remediation. The situation could cause operational delays and potential administrative burdens while awaiting replacements or refunds.
Recalls and identifiers are listed in the FDA enforcement report linked in the source data. The device label or owner manual may also show UDI/DI and serial numbers.
Remedies, including refunds or replacements, are typically processed in 4-6 weeks after eligibility is confirmed.
Keep the recall notice, serial numbers, UDI/DI, and all correspondence. Photograph labels and document dates.
Model numbers include UDI/DI 08436046002166 and multiple serial numbers such as G71453, G70953, G70930, G70537, G70757, G70797, G70275, G71257, G71983, G71975, G71467, G69702, G71440, G71329, G70244, G70955, G71462, G71320, G71451. 55 units recalled. Distribution limited to the United States, specifically California, Illinois and New Jersey. Recall date 2025-06-10. Status: ACTIVE.
No injuries or incidents have been reported.
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