FDA Device recall Z-0246-2026

Model Number 40KWFXPLUS, Mobile X-ray system

FDA Device
Class II
ongoing
Published 2025-10-29

On 2025-10-29 the FDA classified a Class II recall of Model Number 40KWFXPLUS, Mobile X-ray system 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-0246-2026
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 40KWFXPLUS, 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 08436046002166, Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193,… UDI/DI 08436046002166, Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193, G80165, G79928, G76507, G79861, G80255, G80202, G82594, G79057, G73017, G80154, G73616, G73471, G76479, G79615, G80179, G79467, G79827, G79840, G79877, G79926, G78011, G78726, G82574, G82638, G73651, G75438, G77820, G78050, G79426, G79634, G82590, G72392, G73520, G73524, G73627, G73642, G73653, G76730, G76888, G78212, G78279, G78296, G78305, G78323, G82156, G83117, G83133, G73624, G82557, G84603, G84633, G84634, G84641, G84642, G84753, G84778, G84795, G84857, G84869, G84882, G84884, G84900, G84901, G84902, G84911, G84912, G85513, G85514, G85516, G85527, G85528, G79115, G79915, G72362, G75112, G75515, G79299, G79324, G73453, G79625, G77328, G75676, G75744, G75439, G78129, G78141, G76110, G76545, G78000, G80042, G73460, G75100, G75502, G84782, G79794, G83972, G84025, G79936, G84487, G75404, G73457, G75085, G79927, G75388, G73609, G76560, G78992, G82079, G82095, G84014,

code_info

UDI/DI 08436046002166, Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193,…

UDI/DI 08436046002166, Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193, G80165, G79928, G76507, G79861, G80255, G80202, G82594, G79057, G73017, G80154, G73616, G73471, G76479, G79615, G80179, G79467, G79827, G79840, G79877, G79926, G78011, G78726, G82574, G82638, G73651, G75438, G77820, G78050, G79426, G79634, G82590, G72392, G73520, G73524, G73627, G73642, G73653, G76730, G76888, G78212, G78279, G78296, G78305, G78323, G82156, G83117, G83133, G73624, G82557, G84603, G84633, G84634, G84641, G84642, G84753, G84778, G84795, G84857, G84869, G84882, G84884, G84900, G84901, G84902, G84911, G84912, G85513, G85514, G85516, G85527, G85528, G79115, G79915, G72362, G75112, G75515, G79299, G79324, G73453, G79625, G77328, G75676, G75744, G75439, G78129, G78141, G76110, G76545, G78000, G80042, G73460, G75100, G75502, G84782, G79794, G83972, G84025, G79936, G84487, G75404, G73457, G75085, G79927, G75388, G73609, G76560, G78992, G82079, G82095, G84014,

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-0246-2026%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.