SEDECAL SA: Medical Device Recall in 2025 - (Recall #: Z-0258-2026)

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:

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

Product Classification:

Class II

Date Initiated: June 10, 2025

Date Posted: October 29, 2025

Recall Number: Z-0258-2026

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: 39 units

Code Information:

UDI/DI 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684.

Distribution Pattern:

US: CA, IL, and NJ

Voluntary or Mandated:

Voluntary: Firm initiated