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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Recall Number Z-0475-2013
Classification Class II
Code Info All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
Product Distributed Qty 623 units
Reason For Recall With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.

Event Detail

Event Id 63619
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Inc.
City Andover
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Eastonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Lybia, Malta, Mexico, Netherlands, New Zealnd, Norway, Oman, Polnad, Protugual, Quatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Soth Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.