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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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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
Distribution Pattern Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.

Product Detail

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Eleva Universal Fluoroscopic applications 706050, 706083, 706088 Class II The delivered application software was an outdated version to the model of equipment. 19 devices Z-0431-2014