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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62884
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Inc.
City Andover
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-14
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Worldwide Distribution - USA including OH and WA and the country of Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003 Class II Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm. 4 systems Z-2384-2012
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