Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 22, 2017
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 com
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 Broa…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc. recalled Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image… - a moderate-severity action.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image… was recalled by Siemens Medical Solutions USA, Inc. in November 22, 2017. Reason: The Broad Quantification option of the Symbia product software version VB20A may not allow modification of tw…. Check the official notice for the remedy. Verify recall #Z-0094-2018 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-The Broad Quantification option of the Symbia product software version VB20A may not allow modification of tw….
- Moderate
- severity level
- 2 units
- affected scope
- Class II
- classification
- November 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0094-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0094-2018) was formally reported on November 22, 2017, with the manufacturer initiating the action on November 7, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc. is listed as the recalling firm, operating out of Hoffman Estates, IL. Federal records list the affected scope as 2 units.
The documented reason for this recall is: 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 wi… Distribution data in the federal record shows the product reached: Worldwide Distribution to Malaysia, France, Japan, Reunion Island. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2 units
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0094-2018 |
| Date reported | November 22, 2017 |
| Date initiated | November 7, 2017 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Hoffman Estates, IL |
| Affected scope | 2 units |
| Distribution | Worldwide Distribution to Malaysia, France, Japan, Reunion Island |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0094-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 2 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2017. Severity: Moderate. Recall number: Z-0094-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution to Malaysia, France, Japan, Reunion Island.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0094-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 22, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.