Date Initiated by Firm |
November 19, 2011 |
Date Posted |
March 29, 2012 |
Recall Status1 |
Terminated 3 on August 26, 2020 |
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/ 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 |
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
|
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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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