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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Recall Number Z-2275-2012
Classification Class II
Code Info Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.
Product Distributed Qty 14
Reason For Recall There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

Event Detail

Event Id 62679
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
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