CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report

The Symbia Intevo Excel is a non-diagnostic Spect ICT recalled

Siemens Medical Solutions USA is recalling The Symbia Intevo Excel is a non-diagnostic Spect ICT system with CT support for only, distributed nationwide in the US. The recall was initiated on 12 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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

Quantity recalled6 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0913-2015
FDA event ID: 69114
Recalling firm: Siemens Medical Solutions USA, Hoffman Estates, IL
Classification: Class II
Status: Terminated
Recall initiated: 12 Aug 2014
FDA classified: 6 Jan 2015
Reported: 14 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

12 Aug 2014	Recall initiated by company
6 Jan 2015	Classified by FDA	+147 days
14 Jan 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 69114

This product is part of a recall event; the main page for the event is The Siemens Symbia S series is intended recalled.

Reported	Class	Recall	Company	Reason	Where
14 Jan 2015	CLASS II	The Siemens Symbia S series is intended recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
14 Jan 2015	CLASS II	The Siemens Symbia T series is intended recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide

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