22

Nov

2017

SPECT/CT System Cl II Symbia Intevo 16

0

Company:Siemens Medical Solutions USA, Inc..
Date of Enforcement Report 11/22/2017
Class lI:

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 the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Serial Number: 2141, 2144
Recall Number Z-0094-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc.,Hoffman Estates, IL on 11/7/2017. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
Worldwide Distribution to Malaysia, France, Japan, Reunion Island

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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