Z-0285-2026 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
- 3 units
Product Description
SM_40HF_B_D_VIR3.004, 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: G73023, G87352, G80066.