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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 Recall
Philips Healthcare EasyDiagnost Eleva DRF 4.0
see related information
Date Posted March 27, 2012
Recall Status1 Open
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, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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