Class 2 Device Recall RadPRO Mobile 40kW; RadPRO Mobile 40kW FLEXPLUS

• Date Initiated by Firm: June 10, 2025
• Date Posted: October 23, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0246-2026
• Recall Event ID: 97075
• 510(K)Number: K161345
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: Model Number 40KWFXPLUS, Mobile X-ray system
• Code Information: 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, G75375, G75503, G75516, G73621, G73648, G72971, G77213, G79889, G77605, G79311, G75961, G77789, G84028, G73015, G73063, G78873, G79663, G79275, G73027, G76887, G79277, G79357, G76126, G75980, G76125, G76844, G77073, G77089, G77191, G77425, G73079, G75867, G83920, G84017, G77609, G77653, G84591, G75904, G75905, G73147, G73059, G77583, G77641, G77768, G77854, G77870, G77928, G84038, G72363, G73052, G75661, G75662, G75691, G84052, G72972, G73084, G73119, G76757, G76803, G84066, G77780, G73040, G73038, G73139, G75705, G76156, G76721, G84064, G79616, G82140, G82141, G82159, G83203, G75012, G79183, G79806, G70809, G79037, G79182, G80186, G76831, G77408, G79899, G82499, G75451, G75111, G73469, G82158, G80068, G84867, G75114, G75437, G77338, G76250, G77218, G77394, G79432, G79025, G83227, G79102, G79427, G77788, G75011, G75039, G83228, G79060, G78090, G80244, G80090, G82558, G76109, G72422, G75422, G76285, G77178, G78009, G78023, G78052, G78062, G78080, G78697, G78713, G78749, G78896, G79585, G79623, G82157, G83105, G83137, G77144, G75592, G76234, G76579, G78947, G77123, G82591, G78962, G79105, G80180, G79341, G79393, G84754, G76439, G75387, G73463, G73472, G79297, G80153.
• Recalling Firm/ Manufacturer: SEDECAL SA; Pelaya, 9 Pol.; Pol. Ind. Rio De Janeiro; Algete Spain
• For Additional Information Contact: Marie Luisa Gomez de Aguero; 8473946960
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: Sedecal emailed their distributors on 06/10/2025 to remind them 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. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.
• Quantity in Commerce: 268 units
• Distribution: US: CA, IL, and NJ
• 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