Recall Z-1297-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1297-2015
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: K952109. Product: E.CAM emission computed tomography 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

K952109 — IP500 NUCLEAR GAMMA CAMERA SYSTEMSiemens Medical Solutions USA, Inc.·cleared 1995-08-23

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

E.CAM emission computed tomography 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.