Z-0251-2026 Class II Ongoing
FDA device recall Z-0251-2026 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-710CW, 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: G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G79699, G84605.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0251-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026