SEDECAL SA: Medical Device Recall in 2025 - (Recall #: Z-0244-2026)

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 40KWFX, Mobile X-ray system

Product Classification:

Class II

Date Initiated: June 10, 2025

Date Posted: October 29, 2025

Recall Number: Z-0244-2026

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: 55 units

Code Information:

UDI/DI 08436046002166, Serial Numbers: G71453, G70953, G70930, G70537, G70757, G70797, G70275, G71257, G71983, G71975, G71467, G69702, G71440, G71329, G70244, G70955, G71462, G71320, G71451, G71466, G71335, G71446, G65260, G70951, G70814, G70931, G70942, G71991, G70261, G72080, G69697, G71978, G70938, G70247, G70250, G70947, G69706, G78917, G70943, G71343, G71345, G71346, G71258, G70527, G69551, G71442, G71977, G71987, G72083, G70242, G72111, G70256, G70806, G71339, G69547.

Distribution Pattern:

US: CA, IL, and NJ

Voluntary or Mandated:

Voluntary: Firm initiated