Z-0249-2026 Class II Ongoing
FDA device recall Z-0249-2026 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: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 29, 2025
- Initiation Date
- Jun 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Model Number 40KWFXPLUS.005, 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 08436046002166, Serial Numbers: G82576, G82871, G72391, G74872, G75722, G76782, G75035, G75723, G78884, G70532, G73630, G82077.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0249-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026