Company: Siemens Healthcare Diagnostics, Inc..
Date of Enforcement Report:3/26/2014
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Recall Number Z-1216-2014
Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis..
Siemens Healthcare Diagnostics, Inc., Newark, DE on 1/27/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally