Recall Z-2219-2012— Siemens Medical Solutions, USA, Inc

Name: FDA recall Z-2219-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-13

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions, USA, Inc, initiated 2012-07-13, terminated 2013-07-15. It names one FDA 510(k) clearance: K102150. Product: syngo Dynamics Version 9.5. Reason: If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study..

Recalling firm: Siemens Medical Solutions, USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Terminated: 2013-07-15
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K102150 — SYNGO DYNAMICS, VERSION 9.0Siemens Medical Solutions USA, Inc.·cleared 2010-10-05

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 Version 9.5

Reason for recall

If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.

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