FDA Device recall Z-0271-2026

Model Number SM-40HF-B-D-C

FDA Device
Class II
ongoing
Published 2025-10-29

On 2025-10-29 the FDA classified a Class II recall of Model Number SM-40HF-B-D-C by Sedecal, citing 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, cle….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0271-2026
Classification	Class II
Status	ongoing
Initiated	2025-06-10
Published	2025-10-29
Last updated	2026-09-13 11:57 UTC
Company	Sedecal
Distribution	CA, IL, NJ

Product

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

Reason

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.

Identifiers

code_info	UDI/DI 08436046001510, Serial Numbers: D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36… UDI/DI 08436046001510, Serial Numbers: 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, G376

code_info

UDI/DI 08436046001510, Serial Numbers: D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36…

UDI/DI 08436046001510, Serial Numbers: 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, G376

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0271-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.