Device product
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
Z-0273-2026
Product summary
- Firm
- SEDECAL SA
- Event
- Event 97075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0273-2026
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 08436046001510, Serial Numbers: G37158, G61698, G62863, G41192, G62814, G41098, G62566, G60400, G63392, G60406.
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.