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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Event Detail

Event ID 61877
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Inc.
City Andover
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-11
Initial Firm Notification of
Consignee or Public
Distribution Pattern 6 US customers

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system All systems with Eleva software version 4.x and stitching option. Class II 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 executed unnecessarily. Usability is identified to be the main contributing factor. 6 Z-1821-2012