Siemens Medical Solutions USA, Inc. 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 pro Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 pro
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Siemens Medical Solutions USA, Inc. is recalling The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation co due to Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may ca. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026