Skip to content
Recall Observatory FDA recall evidence

Device product

SM_40HF_B_D_VIR3, Mobile X-ray system

Z-0284-2026

June 10, 2025

Class II

Product summary

Firm
SEDECAL SA
Event
Event 97075
Status
Ongoing
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-0284-2026

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: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452.

Distribution pattern: US: CA, IL, and NJ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.