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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Easy Diagnost Eleva Universal Fluoroscopic applications
Recall Number Z-0431-2014
Classification Class II
Code Info 706050, 706083, 706088
Product Distributed Qty 19 devices
Reason For Recall The delivered application software was an outdated version to the model of equipment.

Event Detail

Event Id 66705
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems, Inc.
City Andover
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
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