Siemens Symbia Intevo SPECT CT Systems Recalled for Detector Motion
Siemens is recalling six Symbia Intevo SPECT CT systems worldwide because unintended detector motion may cause patient compression injuries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential patient compression injuries.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling six Symbia Intevo Excel SPECT CT systems. These are non-diagnostic imaging systems used by health care professionals to aid in detecting, localizing, and diagnosing various diseases and disorders. The recall covers specific serial numbers for the Symbia Intevo 6, Symbia Intevo 16, and Symbia Intevo Excel models.
The recall was initiated after Siemens received reports of unintended radial motion of the detectors. According to the source text, this unintended motion may cause patient compression-related injuries if it occurs. The affected systems were distributed nationwide in the United States and internationally to numerous countries.
Health care facilities with these systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. Consumers and patients should consult their health care providers regarding the recall and any necessary follow-up actions.
The recalled product
- 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
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 1) Symbia Intevo 6: Product Number: 10764803
- Serial Numbers: 1001
- 1002
- 2) Symbia Intevo 16
- Product Number: 10764804
- 3) Symbia Intevo Excel
- Product Number: 10764801
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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