Z-0282-2026 Class II Ongoing
FDA device recall Z-0282-2026 was initiated by SEDECAL SA on June 10, 2025 and is designated Class II. 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 po… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2025
- Initiation Date
- June 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 Pattern
US: CA, IL, and NJ
Code Information
UDI/DI unknown, Serial Numbers: 40116