Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1216-2014 — syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673

U.S. FDA — Device Enforcement · United States · 2014-01-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1216-2014
Date of alert
2014-01-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10091804
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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