Company:Philips Medical Systems Nederlands
Date of Enforcement Report 3/28/12
Class lll:

PRODUCT
1) 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 # Z-1196-2012;

2) 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. Recall # Z-1197-2012

REASON
Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems Nederlands, Best, Netherlands, by letter dated February 21, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1) 39; 2) 192

DISTRIBUTION
Nationwide and Internationally