SEDECAL SA: Medical Device Recall in 2025 - (Recall #: Z-0262-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

Product Classification:

Class II

Date Initiated: June 10, 2025
Date Posted: October 29, 2025
Recall Number: Z-0262-2026
Event ID: 97075
Reason for Recall:

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.

Status: Ongoing
Product Quantity: 8 units
Code Information:

UDI/DI 08436046001527, Serial Numbers: 151248, G23340, C05006-W, G22215, G27497/584, 7034, G25402, G25910.

Distribution Pattern:

US: CA, IL, and NJ

Voluntary or Mandated:

Voluntary: Firm initiated