Mobilediagnost Wdr

• • Ongoing Z-0243-2026 FDA Class II ·initiated 10 Jun 2025

  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.

• • Ongoing Z-1083-2024 FDA Class II ·initiated 14 Oct 2021

  While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

• • Terminated Z-1084-2016 FDA Class II ·initiated 18 Jan 2016

  This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.

• • Terminated Z-1691-2016 FDA Class II ·initiated 23 Mar 2015

  Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.

• • Terminated Z-1040-2015 FDA Class II ·initiated 6 Aug 2014

  Reports of unexpected movement.

• • Terminated Z-0508-2015 FDA Class II ·initiated 8 Apr 2014

  In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.

• • Terminated Z-1964-2013 FDA Class II ·initiated 11 Jun 2013

  The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).

• • Terminated Z-1706-2017 FDA Class II ·initiated 28 Nov 2012

  When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

1. 19 Jul 2011 Cleared FDA 510(k) K111725
2. 28 Nov 2012 Recall initiated FDA recalls Z-1706-2017
3. 11 Jun 2013 Recall initiated FDA recalls Z-1964-2013
4. 8 Apr 2014 Recall initiated FDA recalls Z-0508-2015
5. 6 Aug 2014 Recall initiated FDA recalls Z-1040-2015
6. 23 Mar 2015 Recall initiated FDA recalls Z-1691-2016
7. 18 Jan 2016 Recall initiated FDA recalls Z-1084-2016
8. 14 Oct 2021 Recall initiated FDA recalls Z-1083-2024
9. 10 Jun 2025 Recall initiated FDA recalls Z-0243-2026

510(k) Number

K111725 ↗

FDA product code

IZL

Device class

Class II

Regulation

21 CFR Part 892.1720

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

• PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS by Prognosys Medical Systems Private Limited
• AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS by Virtual Imaging, Inc.
• Amadeo M-DR Mini, Amadeo M-AX Mini by OEHM UND REHBEIN GMBH
• MINE ALNU (Model: Mine 2.1) by Hdt Co., Ltd.
• Micro C Medical Imaging System, M01 by Oxos Medical
• RAYMO Mobile X-ray System (Model: RAYMO) by DRGEM Corporation
• EzRay M18 (Model: VMX-P400) by VATECH CO., LTD.
• BETA I & BETA II by Porta Ray, Inc.
• XLITE by GEMSS HEALTHCARE CO., LTD.
• CP 100/30 by Micro-Focus Imaging., Inc.

• Sedecal Net 4000-St

  Class II

  GUDID on market

• Sedecal SHFR400

  Class I

  CE/MDR GUDID on market

• MobileDiagnost wDR 2.2 Open recall

  Class II

  FDA 510(k) K191813 Active Cleared 2 Aug 2019

• Sedecal Sm-40HF-B-D-C Open recall

  Class II

  CE/MDR FDA 510(k) K090322 Active Cleared 17 Mar 2009 +1authorizations

See all devices from Sedecal., Sa. →