Recall Z-1296-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1296-2015
Creator: U.S. Food and Drug Administration
Published: 2012-04-11

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2012-04-11, terminated 2016-12-23. It names one FDA 510(k) clearance: K072567. Product: Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.. Reason: Radial motor drives replaced during a customer service action were incorrectly assembled backwards..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-04-11
Terminated: 2016-12-23
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K072567 — SYMBIA-E, MODEL 10275879Siemens Medical Solutions USA, Inc.·cleared 2007-10-30

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

Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.

Reason for recall

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

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