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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare MD Eleva system

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 Class 2 Recall
Philips Healthcare MD Eleva system
see related information
Date Posted March 29, 2012
Recall Status1 Open
Recall Number Z-1212-2012
Recall Event ID 61028
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
Code Information MultiDiagnost Eleva II - 708036, 708032, MultiDiagnost Eleva FD - 708037, 708034,
Recalling Firm/
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.
FDA Determined
Cause 2
DESIGN: Software Design
Action A field correction action will be undertaken to correct the software error in affected systems worldwide. Your proposed action to bring the product into compliance with regulatory requirements is to institute a worldwide field correction to replace the software error in affected systems by updating the current software to version R6.1.2. The timeframe for completion of this field action will be 6 months post field action publication. Preventive actions: The software has been corrected moving forward in subsequent releases for these products. For further questions please call (978) 787-1501.
Quantity in Commerce 92 ( 24 Eleva 11s, and 68 Eleva FDs )
Distribution Worldwide Distribution - USA (nationwide)
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.