Class 2 Device Recall MobileDiagnost wDR MobileDiagnost wDR 2.0 MobileDiagnost wDR 2.2

• Date Initiated by Firm: October 14, 2021
• Date Posted: February 14, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1083-2024
• Recall Event ID: 93651
• 510(K)Number: K111725 K141895 K191813
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
• Code Information: Model 712001 - UDI-DI 00884838028586, all serial numbers; Model 712002 - UDI-DI 00884838082373, all serial numbers; Model 712004 - UDI-DI 08436046002173, all serial numbers; Model 712006 - UDI-DI 00884838091504, serial numbers: SN20410556 and SN21410184; Model 712007 - UDI-DI)08436046002357, serial numbers: 26, 27, 19410038, 19410044, 19410046, 21410261, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410339, 21410340, 21410341, 21410342, 21410345, 22410022, 22410023, SN0410157, SN1410049, SN19410034, SN19410035, SN19410036, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410129, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, SN20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410555, SN20410556, SN20410557, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410094, SN21410099, SN21410103, SN21410104, SN21410105, SN21410117, SN21410118, SN21410119, SN21410130, SN21410131, SN21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, SN21410213, SN21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, and SNZY204110015.
• Recalling Firm/ Manufacturer: SEDECAL SA; PELAYA, 9 POL.; POL. IND. RIO DE JANEIRO; Algete Spain
• For Additional Information Contact: Devan Moser; 847-394-6960
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Use error
• Action: The distributor in the U.S., Philips, issued letters to consignees dated 05-October-2021 and flagged "IMPORTANT PRODUCT NOTICE" via certified mail on 10/14/2021. The letter explained the problem and under what circumstances it can occur, how to identify whether the consignee has the affected product, and the actions that can be taken to minimize the effect of the problem. The consignee is to: (1) Circulate this notice to all users of the device so that they are aware of the issues; (2) Attach this notice as an addendum to the MobileDiagnost wDR IFU for ease of reference; (3) If unintended motion occurs, press Emergency Stop button to prevent further movement, allow unit to dry and once dry, the system will move as intended, and if the problem persists, contact their local Philips representative and reference the FCO number provided; (4) During cleaning, do not use wet wipes, liquids, and do not spray disinfectants directly on the buttons since this may cause electrical short circuits or metal corrosion, and follow the cleaning instructions provided in the Maintenance, Cleaning and Disposal section of the instruction for use. For actions planned by Philips to correct the problem, the notice says Philips is providing this customer letter containing guidance and alternative process steps to mitigate potential issues. An Important Product Notice Acknowledgement Form was attached for completion and return to Philips no later than 30 days from receipt. The form is to confirm receipt of the Important Product Notice, understanding of the issue, and required actions to be taken.
• Quantity in Commerce: 851 devices
• Distribution: US Nationwide distribution. There was government distribution but no military distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IZL and Original Applicant = SEDECAL SA