FDA Device

EasyDiagnost Eleva Part Number 989605071921

Hazard

When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.

What You Should Do

Remedy

The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.

Products

EasyDiagnost Eleva Part Number 989605071921
Brand
Philips Medical Systems Sales & Service Region No. America
UPC
The firm uses site numbers instead of serial numbers. 103164, 105323, 505806, 500032, 105589, 105337, 506439, 505063, 505749, 505653, 505295, 105152, 505385, 505003, 506211, 504541, 505015, 504981, 504611, 104179, 505754, 505671, 505104, 103539, 102551, 505069, 102549, 504962, 104812, 504743, 105777, 103515, 103522, 103523, 103588, 504966, 504882, 505056, 504879, 105921, 505798, 105640, 105776, 506199, 504804, 504803.

Units Affected

46