ClearanceBrief
Recall Z-1088-03 ยท LLZ System, Image Processing, Radiological

Siemens Medical Solutions USA, Inc

Leonardo Workstations with software version 2022A/B, 2003A

DateAug 7, 2003 (initiated Feb 28, 2003)
StatusTerminated
Reasonsoftware problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
Root causeOther
ActionThe recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.
Quantity1374 units
DistributionThe product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K010938SYNGO MULTIMODALITY WORKSTATION
Siemens Medical Solutions USA, Inc., Jun 26, 2001