Sedecal recalled 56 Mobile Digital Diagnostic X-Ray Systems on June 10, 2025. The recall affects the SM-40HF-B-D-KM (AeroDR X30) model due to water resistance concerns. Users must stop using the device immediately and follow cleaning instructions to avoid potential hazards.
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
The recall involves Sedecal Mobile Digital Diagnostic X-Ray Systems, model SM-40HF-B-D-KM (AeroDR X30), with serial numbers including G-81478, G81924, and others. These devices were distributed in California, Illinois, and New Jersey.
The manufacturer reminded users that the equipment is not water-resistant. Improper cleaning can lead to malfunction and significant health risks.
No specific incidents or injuries have been reported related to this recall, but improper use poses high risks.
Stop using the device immediately. Contact SEDECAL SA or your healthcare provider for further instructions and follow the cleaning guidelines provided.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0242-2026 or contact SEDECAL SA.
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