Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 19, 2016
Symbia T Series SPECT + CT Product Usage 1) 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 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3
The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bear…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc. recalled Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distributio… - a moderate-severity action.
Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distributio… was recalled by Siemens Medical Solutions USA, Inc. in October 19, 2016. Reason: The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically…. Check the official notice for the remedy. Verify recall #Z-0062-2017 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- October 19, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0062-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0062-2017) was formally reported on October 19, 2016, with the manufacturer initiating the action on August 16, 2013. 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 1109 units.
The documented reason for this recall is: The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearin… Distribution data in the federal record shows the product reached: Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, N…. 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
1109 units
Related Recalls
6
3 from same agency
Product description
Symbia T Series SPECT + CT Product Usage 1) 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 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.
Reason for recall
The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0062-2017 |
| Date reported | October 19, 2016 |
| Date initiated | August 16, 2013 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Hoffman Estates, IL |
| Affected scope | 1109 units |
| Distribution | Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United K… |
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-0062-2017) 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 T Series SPECT + CT Product Usage 1) 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 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 1109 units.
Why was this product recalled? ▼
The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0062-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwan, Australia, Bangladesh, Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Hong Kong, Croatia, Hungary, Indonesia, Iran, Israel, India, South Korea, Kuwait, Kazakhstan, Lithuania, Latvia, Morocco, Mexico, Norway, New Zealand, Peru, Phillipines, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Taiwan, Venezuela, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0062-2017) 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 October 19, 2016. 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.