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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Recall Number Z-2384-2012
Classification Class II
Code Info Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003
Product Distributed Qty 4 systems
Reason For Recall 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.

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