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.
Recall
- Recall Number
- Z-1196-2012
- Event Number
- 61267
- Firm
- Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands
- FEI Number
- 3002807880
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- February 24, 2012
- Posted
- March 9, 2012
- Terminated
- March 26, 2013
Description
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.
Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
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.
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
14 units US; 25 units International