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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall RadPRO Mobile 40kW; RadPRO Mobile 40kW FLEXPLUSsee related information
Date Initiated by FirmJune 10, 2025
Date PostedOctober 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0244-2026
Recall Event ID 97075
510(K)NumberK161345 
Product Classification System, x-ray, mobile - Product Code IZL
ProductModel Number 40KWFX, Mobile X-ray system
Code Information UDI/DI 08436046002166, Serial Numbers: G71453, G70953, G70930, G70537, G70757, G70797, G70275, G71257, G71983, G71975, G71467, G69702, G71440, G71329, G70244, G70955, G71462, G71320, G71451, G71466, G71335, G71446, G65260, G70951, G70814, G70931, G70942, G71991, G70261, G72080, G69697, G71978, G70938, G70247, G70250, G70947, G69706, G78917, G70943, G71343, G71345, G71346, G71258, G70527, G69551, G71442, G71977, G71987, G72083, G70242, G72111, G70256, G70806, G71339, G69547.
Recalling Firm/
Manufacturer		 SEDECAL SA
Pelaya, 9 Pol.
Pol. Ind. Rio De Janeiro
Algete Spain
For Additional Information ContactMarie 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 2		Device Design
ActionSedecal 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 Commerce55 units
DistributionUS: CA, IL, and NJ
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZL
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