Z-0913-2015Class II

The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction...

Name: Z-0913-2015 The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2014-08-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-08-12 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc. began a recall of The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo... on 2014-08-12. FDA classified it as Class II and gives the reason as "Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0913-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-12
Posted: 2015-01-06
Terminated: 2016-12-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. 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 5S8keV. CT: The CT component is intended to produce cross-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. 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 patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent Customer Safety Advisory Notice letters to all customers of record. The letters instructed customers to: 1) continue to use their system(s); 2) place the safety advisory in the system's instructions for use; and, 3) to anticipate that their local service engineer will contact them to perform an inspection and schedule any necessary repairs by December 2014. Customers were also instructed to share the letter with their support staff and, if the equipment was sold or transferred, to forward the safety notice to the new owner of the equipment. Customers with questions can contact their local service representative or Siemens Medical Solutions at 800-888-7436.
Quantity in commerce: 6 systems
Distribution: Worldwide Distribution - USA (naitonwide) and Internationally to Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
Product codes and lots: 1) Symbia Intevo 6: Product Number: 10764803; Serial Numbers: 1001 ; 1002 ; 2) Symbia Intevo 16; Product Number: 10764804; Serial Numbers: 1001 ; 1002 ; 3) Symbia Intevo Excel; Product Number: 10764801; Serial Numbers: 1001 ; 1002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0913-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0911-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-06
Z-0912-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-06
Z-0913-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-06

Product code KPS

K131634Class IISymbiaSiemens Medical Solutions USA, Inc. / cleared 2013-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)