—#76931

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050151
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.

Timeline

Recall initiated: 2008-12-30
Posted by FDA: 2009-09-25
Terminated: 2010-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.