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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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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
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022 Class II 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. 623 units Z-0475-2013