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U.S. Department of Health and Human Services

Class 2 Device Recall Multi Diagnost Eleva with FlatDetector

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 Class 2 Device Recall Multi Diagnost Eleva with FlatDetectorsee related information
Date Initiated by FirmOctober 14, 2013
Date PostedFebruary 26, 2015
Recall Status1 Terminated 3 on January 23, 2017
Recall NumberZ-1045-2015
Recall Event ID 69870
510(K)NumberK050151 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductPhilips Multi Diagnost Eleva with FlatDetector
Code Information Product Code: 708037
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips Healthcare Planned Action: 1. Software updates to SW R6.1.3 through Field Change Orders (FCOs) FCO70800140 and FCO70800142. 2. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by September 1, 2015. For further questions please call (978) 687-1501.
Quantity in Commerce238
DistributionWorldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.
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 = IZI
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