Philips Medical Systems North America Co. Phillips Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used for general R/F, fluoroscopy, radiography, and angiography examinations. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used for general R/F, fluoroscopy, radiography, and angiography examinations.
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
software version 4.3.1 or higher. Units are identified with Site Numbers: 538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927.
Products Sold
software version 4.3.1 or higher. Units are identified with Site Numbers: 538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927.
Philips Medical Systems North America Co. Phillips is recalling Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or high due to System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid sw. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.
Recommended Action
Per FDA guidance
A Customer Notification letter describing the failure, the means, by which a customer can prevent the failure mode from occurring, and actions planned by Philips to correct the problem were sent to all users of the affected systems. Philips will modify the system software and will be installed at no cost to the customer.
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