Recall Z-1197-2012 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems Nederlands
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.
| Date | Mar 9, 2012 (initiated Feb 24, 2012) |
| Status | Terminated |
| Reason | Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values. |
| 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 | 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 Solv |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023441 | PHILIPS MULTIDIAGNOST ELEVA Philips Medical Systems, Oct 30, 2002 |