FDA recall Z-0242-2026

SEDECAL SA · Class II · device

Product

Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

Reason for recall

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.

Distribution

US: CA, IL, and NJ

Key facts

Status
Ongoing
Initiation date
2025-06-10
Report date
2025-10-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Algete, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0242-2026