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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/
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
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.