SEDECAL SA: Medical Device Recall in 2025 - (Recall #: Z-0285-2026)

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:

SM_40HF_B_D_VIR3.004, Mobile X-ray system

Product Classification:

Class II

Date Initiated: June 10, 2025

Date Posted: October 29, 2025

Recall Number: Z-0285-2026

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: 3 units

Code Information:

UDI/DI 08436046002166, Serial Numbers: G73023, G87352, G80066.

Distribution Pattern:

US: CA, IL, and NJ

Voluntary or Mandated:

Voluntary: Firm initiated