CLASS II Device recall · Reported 22 Nov 2017 · FDA Enforcement Report

Symbia Intevo 6, Spect/CT System recalled

Siemens Medical Solutions USA is recalling Symbia Intevo 6, Spect/CT System, Emission Computed Tomography System To detect or image. The recall was initiated on 7 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 2141, 2144

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0094-2018
FDA event ID: 78184
Recalling firm: Siemens Medical Solutions USA, Hoffman Estates, IL
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2017
FDA classified: 16 Nov 2017
Reported: 22 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

7 Nov 2017	Recall initiated by company
16 Nov 2017	Classified by FDA	+9 days
22 Nov 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 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. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles.SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Where it was distributed

Worldwide Distribution to Malaysia, France, Japan, Reunion Island

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number: 2141, 2144

Where was it sold?

Worldwide Distribution to Malaysia, France, Japan, Reunion Island

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 78184

This product is part of a recall event; the main page for the event is Symbia Intevo 16, Spect/CT System recalled.

Reported	Class	Recall	Company	Reason	Where
22 Nov 2017	CLASS II	Symbia Intevo 16, Spect/CT System recalled	Siemens Medical Solutions USA	Device Malfunction	IL

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