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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

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

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 Letter
Distribution Pattern 6 US customers