Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0094-2018 — 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. SPECT: To detect or image

U.S. FDA — Device Enforcement · United States · 2017-11-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0094-2018
Date of alert: 2017-11-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Medical Solutions USA, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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