FDA Recall Open, Classified

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

Recall: Z-0269-2026 · Initiated June 10, 2025

Recall

Recall Number
Z-0269-2026
Event Number
97075
Firm
SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain
FEI Number
3002495042
Product Code
IZL
Status
Open, Classified
Root Cause
Device Design
Initiated
June 10, 2025
Posted
October 23, 2025

Description

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

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.

Action

Sedecal emailed their distributors on 06/10/2025 to remind them 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. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.

Distribution

US: CA, IL, and NJ

Quantity

1 unit