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U.S. Department of Health and Human Services

Class 2 Device Recall Sedecal Soltus

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  Class 2 Device Recall Sedecal Soltus see related information
Date Initiated by Firm August 12, 2022
Date Posted November 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-0182-2023
Recall Event ID 90736
510(K)Number K192936  
Product Classification System, x-ray, mobile - Product Code IZL
Product Sedecal Soltus

Battery Mobile X-Ray System REF Soltus 450


Battery Mobile X-Ray System REF Soltus 500
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
Recalling Firm/
Manufacturer
SEDECAL SA
PELAYA, 9 POL.
POL. IND. RIO DE JANEIRO
Algete Spain
For Additional Information Contact Maria Luisa Gomez De Ag¿ero
8473946960
Manufacturer Reason
for Recall
Due to un-commanded movement of mobile x-ray unit.
FDA Determined
Cause 2
Software design
Action Sedecal SA provided Canon Medical Systems USA (CMSU) the sole distributor of the Soltus system in the U.S. an "URGENT: ADVISORY NOTICE" to communicated to CMSU's customers. On 07/28/2022, CMSU sent the "URGENT: ADVISORY NOTICE" Letter via USPS Certified to inform customer of an issue with erratic movements related with Soltus 500 Mobile X-Ray units. According to reports, the users were trying to turn the systems to the left or to the right when it suddenly started moving backwards at a high speed. Customer are instructed to: 1. Do not continue using the unit when in error condition (magenta LED status lights blinking) if the error cannot be reset. 2. In case of undesired or erratic movements perceived by the user, release the handle and park the unit immediately. Do not try to fight against the erratic movements of the system with the handle. 3. Call service immediately to restore the unit to operational status. 4. If the unit most be moved, power off the unit (do not use the emergency stop button) and use either the manual driving brake release button or the manual clutch screws (See Manual (OM-0474R11) sections 3.6.1.3 and 3.6.1.6 for model Soltus 500. See Manual (OM-0475R7) sections 3.6.1.3 and 3.6.1.5 for model Soltus 450. For questions, contact Gary Becker, Regulatory Affairs Manager at 800-421-1968 or gmbecker@us.medical.canon or the Canon Service Rep at 800-521-1968.
Quantity in Commerce 155 systems
Distribution 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
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 and Original Applicant = Sedecal., SA.
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