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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MultiDiagnost Eleva FD

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  Class 2 Device Recall Philips MultiDiagnost Eleva FD see related information
Date Initiated by Firm February 24, 2012
Date Posted March 09, 2012
Recall Status1 Terminated 3 on March 26, 2013
Recall Number Z-1197-2012
Recall Event ID 61267
510(K)Number K023441  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Philips MultiDiagnost Eleva FD, Software R5.1.x
Model: 708034

Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications.
Code Information Software Version R4.1.x S/N: 3 5 6 8 9 10 12 13 14 15 16 17 18 19 22 23 24 25 26 27 28 29 30 32 33 34 36 37 38 39 40 41 46 47 50 51 52 53 54 55 56 58 60 61 63 64 65 66 67 68 69 70 71 72 73 75 76 77 78 79 80 81 82 83 84 85 88 93 94 95 96 97 98 100 101 103 104 105 106 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 125 126 129 130 131 132 133 134 135 136 137 138 142 143 144 146 147 148 149 151 152 155 157 157 159 160 161 162 167 168 170 174 175 176 177 179 180 181 182 185 186 187 189 190 191 193 194 195 196 197 201 202 204 205 206 207 208 209 210 211 213 213 216 217 219 220 220 221 221 221 222 223 224 225 225 228 233 233 234 235 235 237 237 240 241 241 242 242 244 244 246 246 247 247 249 249 251 251 253 254 254 255 255 257 257 259 261 262 264 265 266 268 269 272 273 277 278 
Recalling Firm/
Manufacturer		 Philips Medical Systems Nederlands
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		 Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare issued Urgent Field Safety Notices dated February 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. No action is necessary by the customer/user. A mandatory Field Safety Correction (FCO) Action will be issued to solve the problem. The FCO will consists of a Software update. For further support customers were instructed to contact their Phillips representative. For questions regarding this recall call 978-687-1501.
Quantity in Commerce 45 US; 20 Canada;142 International=207 units
Distribution Worldwide Distribution - USA (nationwide) and the following countries: Canada, Australia Austria Belgium Bahrain Czech Republic Denmark Estonia France Finland Germany Hong Kong Israel Italy Latvia Luxemburg Malaysia Mexico Netherlands New Zealand Norway Russian Fed SAUDI ARABIA Serbia Slovakia Solvenia South Africa Spain Switzerland Sweden Syria Thailand Turkey United Kingdom
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS
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