Recall Z-0062-2017— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0062-2017
Creator: U.S. Food and Drug Administration
Published: 2013-08-16

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2013-08-16, terminated 2016-12-23. It names one FDA 510(k) clearance: K082506. Product: Symbia T Series SPECT + CT Product Usage 1) SPECT: 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. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.. Reason: The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-16
Terminated: 2016-12-23
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K082506 — SYMBIA, VERSION 4.0Siemens Medical Solutions USA, Inc.·cleared 2008-11-21

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 T Series SPECT + CT Product Usage 1) SPECT: 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. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.

Reason for recall

The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

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