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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Ventri

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 Class 2 Recall
GE Healthcare Ventri
see related information
Date Posted September 17, 2009
Recall Status1 Open
Recall Number Z-2219-2009
Recall Event ID 51309
Premarket Notification
510(K) Numbers
K051855  K920879  K994413 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT. The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.
Code Information Serial Numbers: 11035 11035 11114 11115 11250 0000E3GT08004A 11141 11241 000BOCHTA00266 11274 11006 00000000VEN004 11285 11016 11298 11083 00000000VEN004 11200 11016 0000E3GT08074A 11259 11111 11135 11108 11291 11338 11175 11042 11040 11199 11005 0000INDNVC0041 0000E3GT08080A 11329 11243 11217 11198 11292 11177 11242 11157 11155 11156 11313 11184 11256 11120 11106 11099 11102 11102 0000E3GT08072A 11295 11187 11265 11075 11137 11138 11233 11052 11322 11220 11301 11125 11152 11286 11294 11078 11093 11001 11235 11327 11021 11801 11014 0000000 VEN005 11288 11147 11039 11094 11038 11328 11251 11128 11165 11068 11034 11203 11069 11253 11127 11019 11057 11284 11124 11001 11055 11297 11190 11071 11204 11306 11061 173 11151 11009 11248 11067 11209 11247 11077 11191 11193 11206 11192 11047 11085 11262 11325 11169 11222 11011 11166 11050 11008 11280 11310 0000E3GT08027A 11076 11048 11031 11158 11178 11214 11027 11223 11261 11004 11307 11107 11074 11293 11276 11054 11270 11218 0000E3GT08038A 11142 11145 11244 11170 11046 11092 11060 11260 11188 11275 11302 11012 1117 11179 11087 11088 11150 11149 11255 11176 11089 11056 11015 11279 11017 11320 11146 11324 14351 11273 11059 11045 11230 11101 11148 11315 11104 11044 11237 11123 11022 11303 11082 11287 11080 11084 11212 11269 11043 11299 11119 11130 11278 11051 11053 11070 11122 11098 11024 11025 11300 11116 11232 11180 11063 000E3GT08064A6 0000E3GT08064A 0000E3GT09104A 11018 11131 11263 11210 11033 11030 11213 11211 11330 11194 11173 11134 11162 11185 11066 11308 11167 11153 11172 11164 11226 11208 11112 11282 11196 11304 11181 11227 11264 11267 11289 11277 11311 11026 11290 11224 11221 11118 11002 11003 11029 11182 11143 11058 11105 11100 11032 11215 11246 11201 11113 11109 11296 11091 11272 11312 11252 11159 11271 11321 11234 11216 11132 11020 11133 11064 11195 11072 11305 11314 11317 11316 11219 11062 11245 11103 11323 11007 11205 11202 11281 11129 00000000VEN003 11010 11225 11097 11037 11049 11013 11171 11268 11186
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be implemented in an effort to reduce the probability or repeat occurrence.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action GE Healthcare issued a "Product Safety Notification" dated January 2009 to consignees. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. A GE Field Engineer will visit each site and implement the correction. For further information, contact your local GE Healthcare service representative at 1-800-437-1171 (US or Canada) or 1-262-896-2890 (outside the US).
Quantity in Commerce 308 (252 US, 57 OUS)
Distribution Worldwide Distribution -- US (AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MS, MO, NE, NV, NH, NJ, NY, NC, OH,OK PA, RI,SC, TN, TX, UT, VA, WA, WI and WV), AUSTRALIA, BRAZIL CANADA, DENMARK, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NETHERLANDS, NORWAY,SWEDEN, SWITZERLAND, TURKEY and UNITED KINGDOM.
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 = KPS and Original Applicant = BRAINLAB
510(K)s with Product Code = KPS and Original Applicant = BRAINLAB AG
510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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