Z-1197-2012

Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost Eleva system is intended...

Name: Z-1197-2012 Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost Eleva system is intended...
Creator: Philips Medical Systems Nederlands
Published: 2012-02-24
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2012-02-24 / Terminated / root cause: software

FDA source

Philips Medical Systems Nederlands began a recall of Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal... on 2012-02-24. The reason FDA records is "Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1197-2012
Status: Terminated
Initiated: 2012-02-24
Posted: 2012-03-09
Terminated: 2013-03-26
Recalling firm: Philips Medical Systems Nederland B.V.
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.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Product code IZI

K023441Class IIPhilips Multidiagnost ElevaPhilips Medical Systems / cleared 2002-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)