Company: Siemens Healthcare Diagnostics, Inc..
Date of Enforcement Report:3/26/2014
Class lI:
PRODUCT
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Recall Number Z-1216-2014
REASON
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..
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE on 1/27/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
50p>
DISTRIBUTION
Nationwide and Internationally
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