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U.S. Department of Health and Human Services

Class 2 Device Recall Easy Diagnost

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 Class 2 Recall
Easy Diagnost
see related information
Date Posted June 18, 2012
Recall Status1 Open
Recall Number Z-1821-2012
Recall Event ID 61877
Premarket Notification
510(K) Numbers
K031535  K970640 
Product Classification Table, Radiographic, Tilting - Product Code IXR
Product Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Code Information All systems with Eleva software version 4.x and stitching option.
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
For Additional Information Contact Dominic Siewko
800-722-9377
Manufacturer Reason
for Recall
If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
Quantity in Commerce 6
Distribution 6 US customers
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.
510(K) Database 510(K)s with Product Code = IXR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
510(K)s with Product Code = IXR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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