Z-1196-2012

Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system...

Name: Z-1196-2012 Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system...
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 II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I... 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-1196-2012
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 II Software Version R4.1.x Model: 708032 This 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: 14 units US; 25 units International
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: 284 290 291 293 294 295 296 297 298 299 303 305 306 307 308 309 310 312 314 315 316 317 318 327 329 338 346 349 350 352 353 354 354 355 358 362 365 366 367

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)