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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare EasyDiagnost Eleva DRF 4.0

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  Class 2 Device Recall Philips Healthcare EasyDiagnost Eleva DRF 4.0 see related information
Date Initiated by Firm April 01, 2011
Date Posted March 27, 2012
Recall Status1 Terminated 3 on August 23, 2016
Recall Number Z-1178-2012
Recall Event ID 61311
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips Healthcare EasyDiagnost Eleva DRF 4.0

Stationary X-Ray System with DRF as an option for digital radiography.
Code Information 706037
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 It was discovered in some instances the detector did not reset as quickly as the user prompted a change form one image receptor (auxiliary) to the next, and then back again.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action An Important Electronic Product Radiation Warning letter, dated February 28, 2012, was sent to customers. The letter identified the affected product, a description of the issue, the hazard involved, along with the actions to be taken and planned. Customers were to use one of the three work-a-rounds provided. The issue will be corrected with Field Change Order 70600064, which consists of a Software Update 4.0.2SP Service Pack installed on the system. If further information or support is needed, customers can contact Dominic Siewko at 978-659-7936.
Quantity in Commerce 96
Distribution Worldwide Distribution - Including USA.
Total Product Life Cycle TPLC 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.
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