| | Class 2 Device Recall Sedecal Soltus |  |
| Date Initiated by Firm | August 12, 2022 |
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| Date Posted | November 04, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0182-2023 |
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| 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 |
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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. |
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| Quantity in Commerce | 155 systems |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = IZL
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