Terminated

Symbia S, 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. .

FDA Recall Z-0061-2017 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeKPS

Date Initiated2013-08-16

Date Terminated2016-12-23

Product Quantity732 units

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.

Firm Action

Customers were contacted by a service organization that performed product inspections at their sites.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwan, Australia, Bangladesh, Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Hong Kong, Croatia, Hungary, Indonesia, Iran, Israel, India, South Korea, Kuwait, Kazakhstan, Lithuania, Latvia, Morocco, Mexico, Norway, New Zealand, Peru, Phillipines, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Taiwan, Venezuela, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041166SIEMENS ENHANCED IMAGING SYSTEMSiemens Medical Solutions USA, Inc. · 2004-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.