Philips Medical Systems Sales & Service Region No. America EasyDiagnost Eleva Part Number 989605071921 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EasyDiagnost Eleva Part Number 989605071921
Brand
Philips Medical Systems Sales & Service Region No. America
Lot Codes / Batch Numbers
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.
Products Sold
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.
Philips Medical Systems Sales & Service Region No. America is recalling EasyDiagnost Eleva Part Number 989605071921 due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026