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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 Device Recall Philips Healthcare MD Eleva systemsee related information
Date Initiated by FirmNovember 19, 2011
Date PostedMarch 29, 2012
Recall Status1 Terminated 3 on August 26, 2020
Recall NumberZ-1212-2012
Recall Event ID 61028
Product Classification System, x-ray, angiographic - Product Code IZI
ProductPhilips 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/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
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		Software design
ActionA 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 Commerce92 ( 24 Eleva 11s, and 68 Eleva FDs )
DistributionWorldwide Distribution - USA (nationwide)
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.
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