• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

  • Print
  • Share
  • E-mail
-

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.

Product Detail

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