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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MultiDiagnost Eleva II Software Version R4.1

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  Class 2 Device Recall Philips MultiDiagnost Eleva II Software Version R4.1 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-1196-2012
Recall Event ID 61267
510(K)Number K023441  
Product Classification System, x-ray, angiographic - Product Code IZI
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.
Code Information 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 
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 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
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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