FDA recall Z-0282-2026

Product

SED URS LP, Mobile X-ray system

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-0282-2026