Recall Z-0243-2026
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
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Codes / lots: UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15100127, 15100131, 15100135, 15100138, 15100144, 15100133, 14100034, SN14000127, 15100191, 66690596, 66936848, 15100274, 15100280, 15100276, SN16100008, 16100011, 67905914, 16100037, 16100038…
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-0243-2026
- Initiated
- June 10, 2025
- Posted by FDA
- October 23, 2025
- Product code
- IZL – System, X-Ray, Mobile
- Quantity
- 1198 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-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-0246-2026 Class II | Model Number 40KWFXPLUS, 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 |