# K111725: Mobilediagnost WDR

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Jul 19, 2011 after 29 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981556 (1998). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090322: Easy Moving Plus, SM-XXHF-YY, Sedecal., Sa. (2009) Summary page 1.
- K090625: Wireless Portable Detector FD-W17, Philips Medical Systems North America Co. (2009) Summary page 1.

## Most influential descendants
- K141895: Mobilediagnost WDR (2014), 3 descendants of its own
- K191813: MobileDiagnost wDR 2.2 (2019), 1 descendant of its own
- K233678: Radiography 7000 M (2024), 0 descendants of its own
- K173187: MobileDiagnost M50 (2017), 0 descendants of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-0243-2026: 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 po
- Oct 14, 2021 · Class II · Z-1083-2024: 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 t
- Jan 18, 2016 · Class II · Z-1084-2016: 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 corresp
- Mar 23, 2015 · Class II · Z-1691-2016: 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 dis
- Aug 6, 2014 · Class II · Z-1040-2015: Reports of unexpected movement.
- Apr 8, 2014 · Class II · Z-0508-2015: In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.
- Jun 11, 2013 · Class II · Z-1964-2013: 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).
- Nov 28, 2012 · Class II · Z-1706-2017: 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.

## Indications for use
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Source page: https://510kreport.com/device/K111725
Methodology: https://510kreport.com/methodology