Z-0260-2026 Class II 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
- 14 units
Product Description
Model SM-40HF-B-D-C; 40KW 70C, 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: G13768, G36626, G62493, G39518, G61725, G36211, G36281, G36573, G36581, G61368, G61880, G62037, G61367, G36227.