Recall Z-1216-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1216-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-27

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-01-27, terminated 2015-03-16. It names 2 FDA 510(k) clearances: K102150, K023772. Product: syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673. 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: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-01-27
Terminated: 2015-03-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K102150 — SYNGO DYNAMICS, VERSION 9.0Siemens Medical Solutions USA, Inc.·cleared 2010-10-05
K023772 — KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMAcuson Corp.·cleared 2002-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.