SEDECAL SA: Medical Device Recall in 2025 - (Recall #: Z-0260-2026)

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 SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

Product Classification:

Class II

Date Initiated: June 10, 2025

Date Posted: October 29, 2025

Recall Number: Z-0260-2026

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: 14 units

Code Information:

UDI/DI 08436046001510, Serial Numbers: G13768, G36626, G62493, G39518, G61725, G36211, G36281, G36573, G36581, G61368, G61880, G62037, G61367, G36227.

Distribution Pattern:

US: CA, IL, and NJ

Voluntary or Mandated:

Voluntary: Firm initiated