Reported Jan 14, 2015 · Terminated
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60195-2061
Is this the product you have?
- 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
- SPECTTo detect or image the distribution of radionuclides in the body or organ
- using the following techniquesplanar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV
- CTThe 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
- SoftwareThe 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
- Lot codes and dates
- 1)
- Symbia Intevo 6Product
- Number10764803
- Serial Numbers
100110022) Symbia Intevo 16
- Product Number10764804
- Serial Numbers
100110023) Symbia Intevo Excel
- Product Number10764801
- Serial Numbers
10011002
- Amount recalled
- 6 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.