Device product
Model Number 40KWFXPLUS.889, Mobile X-ray system
Z-0250-2026
Product summary
- Firm
- SEDECAL SA
- Event
- Event 97075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0250-2026
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 08436046002166, Serial Numbers: G77146
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.