Recall Z-0246-2026
Sedecal SA · initiated June 10, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Model Number 40KWFXPLUS, Mobile X-ray system
Codes / lots: 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…
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 taken
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.
Details
- Recall number
- Z-0246-2026
- Initiated
- June 10, 2025
- Posted by FDA
- October 23, 2025
- Product code
- IZL – System, X-Ray, Mobile
- Quantity
- 268 units
- Distribution
- US: CA, IL, and NJ
- Recalling firm
- Sedecal SA, Algete
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0242-2026 Class II | Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0243-2026 Class II | MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0244-2026 Class II | Model Number 40KWFX, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0245-2026 Class II | Model Number 40KW-FX.899, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0247-2026 Class II | Model Number 40KWFXPLUS.002, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0248-2026 Class II | Model Number 40KWFXPLUS.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0249-2026 Class II | Model Number 40KWFXPLUS.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0250-2026 Class II | Model Number 40KWFXPLUS.889, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0251-2026 Class II | Model Number 40KWFXPLUS-710CW, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0252-2026 Class II | Model Number 40KWFXPLUS-710CW.007, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0253-2026 Class II | Model Number 40KWMOBILE3.899, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0254-2026 Class II | Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0255-2026 Class II | Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0256-2026 Class II | Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0257-2026 Class II | Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0258-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0259-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0260-2026 Class II | Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0261-2026 Class II | Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0262-2026 Class II | Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0263-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0264-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0265-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0266-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0267-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0268-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0269-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0270-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0271-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |
| Z-0272-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | 06/10/2025Open, Classified |