Symbia Intevo 6 recall: Software Issue
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using…
Why was Symbia Intevo 6 recalled?
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: 2141, 2144
- Product
- Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using…
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 2 units
- Distribution
- Worldwide Distribution to Malaysia, France, Japan, Reunion Island
- Recall date
- November 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)