Device product
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Z-0261-2026
Product summary
- Firm
- SEDECAL SA
- Event
- Event 97075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-0261-2026
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 08436046001114, Serial Numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240.
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.