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U.S. Department of Health and Human Services

Class 2 Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD)

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 Class 2 Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD)see related information
Date Initiated by FirmDecember 30, 2008
Date PostedSeptember 25, 2009
Recall Status1 Terminated 3 on September 28, 2010
Recall NumberZ-0623-2009
Recall Event ID 50748
510(K)NumberK050151 
Product Classification Stationary X-Ray System - Product Code KPR
ProductPhilips 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.
Code Information 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.  
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact
425-487-7602
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionA 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.
Quantity in Commerce30 systems
DistributionNationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR
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