Device product
Model Number 40KWFXPLUS.004, Mobile X-ray system
Z-0248-2026
Product summary
- Firm
- SEDECAL SA
- Event
- Event 97075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0248-2026
Official wording
Reason: 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.
Code information: UDI/DI unknown, Serial Numbers: G84489, G84504, G84589.
Distribution pattern: US: CA, IL, and NJ
Derived failure modes
-
Unknown
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.