Siemens Symbia Intevo 16 SPECT/CT Software Recall for Data Input Error
Siemens is recalling two Symbia Intevo 16 SPECT/CT systems because a software option may prevent users from modifying specific data input values.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software limitation without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling two units of the Symbia Intevo 16 SPECT/CT System. The recall involves serial numbers 2136 and 2142. These systems were distributed worldwide to Malaysia, France, Japan, and Reunion Island.
The recall is due to a defect in the Broad Quantification option of the Symbia product software version VB20A. This option may not allow the modification of two data input values. The failure occurs when the system is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
Healthcare professionals using these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software limitation.
The recalled product
- Product
- Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System 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 588keV.…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 2
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 (2)
- Serial Number: 2136
- 2142
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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