FDA Device recall Z-0243-2026

MobileDiagnost wDR 2.2

FDA Device
Class II
ongoing
Published 2025-10-29

On 2025-10-29 the FDA classified a Class II recall of MobileDiagnost wDR 2.2 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-0243-2026
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

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, 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 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN1300008… UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15

code_info

UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN1300008…

UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15

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-0243-2026%22

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