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.
FDA Recall Z-1197-2012 · Posted 2012-03-09
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Recalling FirmPhilips Medical Systems Nederlands
Recall StatusTerminated
Product CodeIZI
Date Initiated2012-02-24
Date Terminated2013-03-26
Product Quantity45 US; 20 Canada;142 International=207 units
Reason for Recall
Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
Firm 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.
Root Cause
Software design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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