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U.S. Department of Health and Human Services

Class 2 Device Recall EVOTECH

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 Class 2 Device Recall EVOTECH see related information
Date Posted April 18, 2013
Recall Status1 Terminated on August 22, 2013
Recall Number Z-1150-2013
Recall Event ID 64781
510(K)Number K082392 
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
Product EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004.

Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Code Information Batch Numbers:

5041090177
5041090127
5041090131
5041110307
5041120049
5041120065
5041120076
5041100256
5041110157
5041120133
5040107029
5041110264
5041110265
5041110280
5041100218
5041100219
5041110018
5041110143
5041110079
5041110329
5041110212
5041120155
5041100250
5041110080
5041110174
5041110330
5041110203
5041090103
5041090110
5041100103
5041100104
5041100142
5041090184
5041090185
5041120120
5041120070
5041120073
5041120080
5040107087
5041110158
5041100189
5041100186
5041110189
5041080029
5041080063
5041120034
5041080028
5041080060
5041080064
5041100145
5041100146
5041100151
5041100268
5041120081
5040107065
5041120087
5041120116
5041110111
5041110113
5040107115
5041070037
5041110121
5041110140
5041090067
5041090167
5041090168
5041120154
5041090179
5041110177
5041110112
5041110129
5041110130
5041090069
5041110271
5041070036
5041070044
5041070045
5041090034
5041090054
5041090147
5041100192
5041090203
5041100214
5041100265
5041110186
5041110187
5041100067
5041100071
5041100079
5041110075
5041110078
5041120111
5041100136
5041100164
5041100043
5041100046
5041100047
5041110191
5041100262
5041110155
5041110154
5041110327
5041090128
5041110185
5041120060
5041120108
5041110316
5041110231
5041110246
5041090146
5041110291
5041120203
5041090061
5041090063
5041100068
5041100076
5041100222
5041090205
5041090097
5041090141
5041110182
5041090145
5041090129
5041100257
5041120149
5041120152
5041110127
5041130007
5041130008
5041120137
5041110176
5041110188
5041110183
5041100126
5041100127
5041100156
5041070042
5041080077
5041090108
5041100197
5041110120
5041100162
5041090194
5041110131
5041110142
5041110147
5041120094
5041080071
5041080062
5041090175
5041110172
5041110173
5041120071
5041090182
5041100036
5040107105
5041100248
5041100251
5041120150
5041090090
5041090092
5041100077
5041100081
5041100089
5041100259
5041100167
5041100020
5041100025
5041100220

5041120036
5041100205
5041100211
5041110213
5041120179
5041120185
5041110283
5041110315
5041100233
5041100107
5041100108
5041100116
5041100117
5041110228
5041110247
5041110257
5041110333
5041110238
5041110229
5041100022
5041100017
5041110108
5041100241
5041100232
5041100242
5041110322
5041090015
5041090170
5041100041
5041100010
5041100011
5041120099
5041100038
5041100202
5041110115
5041090112
5041100264
5041090086
5041120124
5041100124
5041100129
5041100266
5041100267
5041120143
5041120202
5041090137
5041090164
5041100102
5041100132
5041120129
5041120132
5041120096
5041090031
5041090169
5041090057
5041090060
5041090101
5041100004
5041090093
5041090099
5041110073
5041120190
5041110239
5041090180
5041120209
5041110161
5041110162
5041090134
5041120172
5041100062
5041110092
5041120023
5041120097
5041110274
5041120088
5041090104
5041090113
5041120174
5041100019
5041110088
5041110106
5041110318
5041100115
5041090087
5041110039
5041100015
5041090161
5041100225
5041110332
5041100002
5041100003
5041120146
5041120114
5041100223
5041110116
5041120199
5041120091
5041110326
5041080070
5040107114
5041080076
5041090091
5041120004
5041100096
5041110263
5041110262
5041110242
5041110255
5041110259
5041120068
5041110205
5041120035
5041080058
5041110219
5041100182
5041090198
5041120213
5041120101
5041100183
5041100074
5041110016
5041110254
5041080078
5041090139
5041120112
5041100048
5041120208
5041090144
5041090140
5041090193
5041100007
5041100128
5041100138
5041100188
5041110284
5041120107
5041120131
5041120169
5041120178
5041120184
5041100180
5041120206
5041110006
5041110012
5041130010
5041130011
5041100080
5041110098
5041110100
5041120103
5041120141
5041080057
5041080065
5041080066
5041080072
5041090098
5041090100
5041090221
5041100024
5041100034
5041100092
5041100023
50411000
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
949-453-6400
Manufacturer Reason
for Recall
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.
FDA Determined
Cause 2
Under Investigation by firm
Action An Urgent Medical Device Field Correction letter dated 3/28/13 was sent to all customers who purchased the EVOTECH Endoscope Cleaner and Reprocessor (ECR). The letter informed the customers of the problems identified and the actions to be taken. Customers are informed that the failure can potentially cause the following outcomes for the cycles listed below: 1. In the Full Reprocessing Cycle (Cleaning and HLD): there is a potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes. 2. In the HLD-Only Cycle: there is potential for an adequate amount of high-level disinfectant solution to be sent through some endoscope channels. If customers observe smoke, then they are instructed to: a. Power OFF the device. b. Report your incident to ASP Professional Services at (888) 783-7723 and select option #2. c. Do not use the device until it has been serviced by ASP. Customers are instructed to return attached buyer return card acknowledging their receipt of this communication. Customers are instructed to contact Stericycle at (866) 761-9566 for any questions related to the field correction.
Quantity in Commerce 761 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FEB and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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