Z-0268-2026 Class II Ongoing
FDA device recall Z-0268-2026 was initiated by SEDECAL SA on Jun 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… The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 29, 2025
- Initiation Date
- Jun 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Model Number SM-40HF-B-D-C; 40KW 55G/60G, 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 08436046001510, Serial Numbers: G35524, G33711.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0268-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026