Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-0271-2026

SEDECAL SA recalls Model Number SM-40HF-B-D-C

SEDECAL SAAlgete, SpainReported Oct 29, 2025 · 8 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Serial #
D11-40KW-F, G36689, G37293, G38198, G38657, G38385 — +175 moreShow all
D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892, G62943, G41083, G41100, G36217, G36537, G60066, G61812, G61812, G63322, G40016, G41203, G41222, G60061, G60063, G60064, G36732, G36751, G41119, G62480, G60418, G61707, G65172, G39639, G41104, G36526, G36601, G37129, G37209, G41244, G62015, G40024, G62828, G60429, G61818, G61873, G60065, G61786, G37430, G36148, G39650, G64186, G65400, G64854, G62626, G62660, G62684, G62687, G62747, G62750, G62762, G62938, G63484, G62804, G64206, G64813, G64179, G62500, G62502, G62565, G62690, G62860, G62867, G62883, G62891, G62947, G36222, G60415, G60070, G37646, G61715, G39589, G37466, G38292, G38173, G38058, G38293, G60069, G62816, G63335, G36244, G36492, G37442, G38613, G40124, G40211, G38190, G40199, G62567, G39809, G38287, G37196, G41256, G61872, G62029, G64891, G62682, G62900, G61311, G37239, G38279, G37678, G38076, G61307, G39808, G40133, G62821, G64883, G60058, G60062, G61867, G37676, G40203, G37422, G62815, G36468, G37413, G40216, G41058, G41066, G63212, G41267, G40227, G60430, G63318, G63328, G63333, G41108, G41109, G61716, G60518, G60652, G61356, G60520, G60597, G39800, G39801, G60582, G39657, G62030, G65393, G65395, G39782, G39791, G61706, G61795, G62053, G62062, G62011, G64512, G64520, G65289, G60576, G60606, G60631, G61339, G39465, G61333, G61337, G38629, G62511, G41218, G60635

What the firm is doing

Sedecal emailed their distributors on 06/10/2025 to remind them 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. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.

DistributionShow details

US: CA, IL, and NJ

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls