Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF...
FDA Device Recall #Z-0182-2023 — Class II — August 12, 2022
Recall Summary
| Recall Number | Z-0182-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 12, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SEDECAL SA |
| Location | Algete, N/A |
| Product Type | Devices |
| Quantity | 155 systems |
Product Description
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Reason for Recall
Due to un-commanded movement of mobile x-ray unit.
Distribution Pattern
U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A
Lot / Code Information
Model: Soltus 450 Type / UDI-DI Code: 10451 /08436046002555 10451-1 / 08436046002562 10451-2 / 08436046002531 10451-3 / 08436046002548 Serial Numbers / UDI Codes: SLS000014 (01)08436046002555(240)10451(11)200700(21)SLS000014 SLS000038 (01)08436046002555(240)10451(11)200800(21)SLS000038 SLS000039 (01)08436046002555(240)10451(11)200800(21)SLS000039 SLS000040 (01)08436046002555(240)10451(11)200900(21)SLS000040 SLS000046 (01)08436046002555(240)10451(11)200900(21)SLS000046 SLS000048 (01)08436046002555(240)10451(11)201000(21)SLS000048 SLS000050 (01)08436046002555(240)10451(11)201000(21)SLS000050 SLS000051 (01)08436046002555(240)10451(11)201000(21)SLS000051 SLS000077 (01)08436046002555(240)10451(11)201100(21)SLS000077 SLS000078 (01)08436046002555(240)10451(11)201000(21)SLS000078 SLS000079 (01)08436046002555(240)10451(11)201100(21)SLS000079 SLS000080 (01)08436046002555(240)10451(11)201100(21)SLS000080 SLS000081 (01)08436046002555(240)10451(11)201100(21)SLS000081 SLS000082 (01)08436046002555(240)10451(11)201100(21)SLS000082 SLS000083 (01)08436046002555(240)10451(11)201100(21)SLS000083 SLS000084 (01)08436046002555(240)10451(11)201100(21)SLS000084 SLS000085 (01)08436046002555(240)10451(11)201100(21)SLS000085 SLS000086 (01)08436046002555(240)10451(11)201100(21)SLS000086 SLS000087 (01)08436046002555(240)10451(11)201100(21)SLS000087 SLS000088 (01)08436046002555(240)10451(11)201100(21)SLS000088 SLS000089 (01)08436046002555(240)10451(11)201100(21)SLS000089 SLS000090 (01)08436046002555(240)10451(11)201200(21)SLS000090 SLS000091 (01)08436046002555(240)10451(11)201100(21)SLS000091 SLS000092 (01)08436046002555(240)10451(11)201100(21)SLS000092 SLS000093 (01)08436046002555(240)10451(11)201100(21)SLS000093 SLS000094 (01)08436046002555(240)10451(11)201100(21)SLS000094 SLS000095 (01)08436046002555(240)10451(11)201100(21)SLS000095 SLS000096 (01)08436046002555(240)10451(11)201100(21)SLS000096 SLS000127 (01)08436046002555(240)10451(11)210400(21)SLS000127 SLS000128 (01)08436046002555(240)10451(11)210400(21)SLS000128 SLS000132 (01)08436046002555(240)10451(11)210400(21)SLS000132 SLS000133 (01)08436046002555(240)10451(11)210400(21)SLS000133 SLS000134 (01)08436046002555(240)10451(11)210400(21)SLS000134 SLS000135 (01)08436046002555(240)10451(11)210600(21)SLS000135 SLS000137 (01)08436046002555(240)10451(11)210700(21)SLS000137 SLS000138 (01)08436046002555(240)10451(11)210800(21)SLS000138 SLS000139 (01)08436046002555(240)10451(11)210800(21)SLS000139 SLS000140 (01)08436046002555(240)10451(11)210800(21)SLS000140 Model: Soltus 500 Type / UDI-DI Code: 10501 / 08436046002456 10501-01 / 08436046002463 10501-02 / 08436046002432 10501-03 / 08436046002449 Serial Numbers / UDI Codes: SLS000002 (01)08436046002456(240)10501(11)200100(21)SLS000002 SLS000003 (01)08436046002456(240)10501(11)200400(21)SLS000003 SLS000005 (01)08436046002456(240)10501(11)200400(21)SLS000005 SLS000006 (01)08436046002456(240)10501(11)200500(21)SLS000006 SLS000007 (01)08436046002456(240)10501(11)200500(21)SLS000007 SLS000008 (01)08436046002456(240)10501(11)200600(21)SLS000008 SLS000009 (01)08436046002456(240)10501(11)200600(21)SLS000009 SLS000011 (01)08436046002456(240)10501(11)200600(21)SLS000011 SLS000012 (01)08436046002456(240)10501(11)200600(21)SLS000012 SLS000013 (01)08436046002456(240)10501(11)200500(21)SLS000013 SLS000015 (01)08436046002456(240)10501(11)200500(21)SLS000015 SLS000016 (01)08436046002456(240)10501(11)200500(21)SLS000016 SLS000017 (01)08436046002456(240)10501(11)200600(21)SLS000017 SLS000019 (01)08436046002456(240)10501(11)200600(21)SLS000019 SLS000021 (01)08436046002456(240)10501(11)200600(21)SLS000021 SLS000022 (01)08436046002456(240)10501(11)200600(21)SLS000022 SLS000023 (01)08436046002456(240)10501(11)200700(21)SLS000023 SLS000024 (01)08436046002456(240)10501(11)200700(21)SLS000024 SLS000026 (01)08436046002456(240)10501(11)200700(21)SLS000026 SLS000027 (01)08436046002456(240)10501(11)200700(21)SLS000027 SLS000028 (01)08436046002456(240)10501(11)200700(21)SLS000028 SLS000029 (01)08436046002456(240)10501(11)200700(21)SLS000029 SLS000031 (01)08436046002456(240)10501(11)200800(21)SLS000031 SLS000032 (01)08436046002456(240)10501(11)200800(21)SLS000032 SLS000033 (01)08436046002456(240)10501(11)200800(21)SLS000033 SLS000034 (01)08436046002456(240)10501(11)200900(21)SLS000034 SLS000035 (01)08436046002456(240)10501(11)200900(21)SLS000035 SLS000036 (01)08436046002456(240)10501(11)200900(21)SLS000036 SLS000037 (01)08436046002456(240)10501(11)200900(21)SLS000037 SLS000042 (01)08436046002456(240)10501(11)200900(21)SLS000042 SLS000043 (01)08436046002456(240)10501(11)200900(21)SLS000043 SLS000044 (01)08436046002456(240)10501(11)200900(21)SLS000044 SLS000045 (01)08436046002456(240)10501(11)201000(21)SLS000045 SLS000052 (01)08436046002456(240)10501(11)200900(21)SLS000052 SLS000053 (01)08436046002456(240)10501(11)201000(21)SLS000053 SLS000054 (01)08436046002456(240)10501(11)201000(21)SLS000054 SLS000055 (01)08436046002456(240)10501(11)201000(21)SLS000053 SLS000056 (01)08436046002456(240)10501(11)201000(21)SLS000056 SLS000057 (01)08436046002456(240)10501(11)201000(21)SLS000057 SLS000058 (01)08436046002456(240)10501(11)201000(21)SLS000058 SLS000059 (01)08436046002456(240)10501(11)201100(21)SLS000059 SLS000060 (01)08436046002456(240)10501(11)201100(21)SLS000060 SLS000061 (01)08436046002456(240)10501(11)201100(21)SLS000061 SLS000062 (01)08436046002456(240)10501(11)201100(21)SLS000062 SLS000063 (01)08436046002456(240)10501(11)201100(21)SLS000063 SLS000064 (01)08436046002456(240)10501(11)201100(21)SLS000064 SLS000065 (01)08436046002456(240)10501(11)201100(21)SLS000065 SLS000066 (01)08436046002456(240)10501(11)201100(21)SLS000066 SLS000067 (01)08436046002456(240)10501(11)201000(21)SLS000067 SLS000068 (01)08436046002456(240)10501(11)201000(21)SLS000068 SLS000070 (01)08436046002456(240)10501(11)201000(21)SLS000070 SLS000072 (01)08436046002456(240)10501(11)201000(21)SLS000072 SLS000073 (01)08436046002456(240)10501(11)201000(21)SLS000073 SLS000074 (01)08436046002456(240)10501(11)201000(21)SLS000074 SLS000075 (01)08436046002456(240)10501(11)201000(21)SLS000075 SLS000076 (01)08436046002456(240)10501(11)201000(21)SLS000076 SLS000097 (01)08436046002456(240)10501(11)201100(21)SLS000097 SLS000098 (01)08436046002456(240)10501(11)201100(21)SLS000098 SLS000099 (01)08436046002456(240)10501(11)201200(21)SLS000099 SLS000100 (01)08436046002456(240)10501(11)201200(21)SLS000100 SLS000101 (01)08436046002456(240)10501(11)201200(21)SLS000101 SLS000102 (01)08436046002456(240)10501(11)201200(21)SLS000102 SLS000104 (01)08436046002456(240)10501(11)201200(21)SLS000104 SLS000105 (01)08436046002456(240)10501(11)201200(21)SLS000105 SLS000106 (01)08436046002456(240)10501(11)201200(21)SLS000106 SLS000107 (01)08436046002456(240)10501(11)201200(21)SLS000107 SLS000108 (01)08436046002456(240)10501(11)201200(21)SLS000108 SLS000110 (01)08436046002456(240)10501(11)201200(21)SLS000110 SLS000111 (01)08436046002456(240)10501(11)201200(21)SLS000111 SLS000112 (01)08436046002456(240)10501(11)201200(21)SLS000112 SLS000113 (01)08436046002456(240)10501(11)201200(21)SLS000113 SLS000114 (01)08436046002456(240)10501(11)201200(21)SLS000114 SLS000115 (01)08436046002456(240)10501(11)201200(21)SLS000115 SLS000116 (01)08436046002456(240)10501(11)201200(21)SLS000116 SLS000117 (01)08436046002456(240)10501(11)210400(21)SLS000117 SLS000118 (01)08436046002456(240)10501(11)210400(21)SLS000118 SLS000119 (01)08436046002456(240)10501(11)210400(21)SLS000119 SLS000120 (01)08436046002456(240)10501(11)210500(21)SLS000120 SLS000122 (01)08436046002456(240)10501(11)210500(21)SLS000122 SLS000123 (01)08436046002456(240)10501(11)210500(21)SLS000123 SLS000124 (01)08436046002456(240)10501(11)210500(21)SLS000124 SLS000125 (01)08436046002456(240)10501(11)210500(21)SLS000125 SLS000126 (01)08436046002456(240)10501(11)210500(21)SLS000126 SLS000142 (01)08436046002456(240)10501(11)210900(21)SLS000142 SLS000143 (01)08436046002456(240)10501(11)210900(21)SLS000143 SLS000144 (01)08436046002456(240)10501(11)210900(21)SLS000144 SLS000145 (01)08436046002456(240)10501(11)210900(21)SLS000145 SLS000146 (01)08436046002456(240)10501(11)211000(21)SLS000146 SLS000147 (01)08436046002456(240)10501(11)211000(21)SLS000147 SLS000148 (01)08436046002456(240)10501(11)211000(21)SLS000148 SLS000149 (01)08436046002456(240)10501(11)211000(21)SLS000149 SLS000150 (01)08436046002456(240)10501(11)211000(21)SLS000150 SLS000151 (01)08436046002456(240)10501(11)211000(21)SLS000151 SLS000152 (01)08436046002456(240)10501(11)211000(21)SLS000152 SLS000153 (01)08436046002456(240)10501(11)211000(21)SLS000153 SLS000155 (01)08436046002456(240)10501(11)211100(21)SLS000155 SLS000156 (01)08436046002456(240)10501(11)211100(21)SLS000156 SLS000157 (01)08436046002456(240)10501(11)211100(21)SLS000157 SLS000158 (01)08436046002456(240)10501(11)211100(21)SLS000158 SLS000159 (01)08436046002456(240)10501(11)211100(21)SLS000159 SLS000160 (01)08436046002456(240)10501(11)211100(21)SLS000160 SLS000161 (01)08436046002456(240)10501(11)211100(21)SLS000161 SLS000162 (01)08436046002456(240)10501(11)211100(21)SLS000162 SLS000163 (01)08436046002456(240)10501(11)211100(21)SLS000163 SLS000164 (01)08436046002456(240)10501(11)211100(21)SLS000164 SLS000166 (01)08436046002456(240)10501(11)211100(21)SLS000166 SLS000167 (01)08436046002456(240)10501(11)211100(21)SLS000167 SLS000169 (01)08436046002456(240)10501(11)211200(21)SLS000169 SLS000171 (01)08436046002456(240)10501(11)211200(21)SLS000171 SLS000173 (01)08436046002456(240)10501(11)211200(21)SLS000173 SLS000174 (01)08436046002456(240)10501(11)211200(21)SLS000174 SLS000175 (01)08436046002456(240)10501(11)211200(21)SLS000175 SLS000176 (01)08436046002456(240)10501(11)211200(21)SLS000176 SLS000177 (01)08436046002456(240)10501(11)211200(21)SLS000177 SLS000178 (01)08436046002456(240)10501(11)211200(21)SLS000178 SLS000179 (01)08436046002456(240)10501(11)211200(21)SLS000179 SLS000180 (01)08436046002456(240)10501(11)211200(21)SLS000180
Other Recalls from SEDECAL SA
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0243-2026 | Class II | MobileDiagnost wDR 2.2; Model Number REF 9890-0... | Jun 10, 2025 |
| Z-0255-2026 | Class II | Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-... | Jun 10, 2025 |
| Z-0275-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW CANON READY, M... | Jun 10, 2025 |
| Z-0248-2026 | Class II | Model Number 40KWFXPLUS.004, Mobile X-ray system | Jun 10, 2025 |
| Z-0270-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobil... | Jun 10, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.