Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 9, 2023
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detec…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc. recalled The following Pro.specta Emission Computed Tomography Systems that were manufactured with… - a moderate-severity action.
The following Pro.specta Emission Computed Tomography Systems that were manufactured with… was recalled by Siemens Medical Solutions USA, Inc. in August 9, 2023. Reason: During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-a…. Check the official notice for the remedy. Verify recall #Z-2256-2023 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-a….
- Moderate
- severity level
- Class II
- classification
- August 9, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2256-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2256-2023) was formally reported on August 9, 2023, with the manufacturer initiating the action on July 12, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Medical Solutions USA, Inc. is listed as the recalling firm, operating out of Hoffman Estates, IL. Federal records list the affected scope as 108 systems.
The documented reason for this recall is: During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patie… Distribution data in the federal record shows the product reached: Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, Fran…. 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
108 systems
Related Recalls
6
3 from same agency
Product description
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
Reason for recall
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2256-2023 |
| Date reported | August 9, 2023 |
| Date initiated | July 12, 2023 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Hoffman Estates, IL |
| Affected scope | 108 systems |
| Distribution | Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Ko… |
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-2256-2023) 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? ▼
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 108 systems.
Why was this product recalled? ▼
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2256-2023.
Where was the recalled product distributed? ▼
Distribution: Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Switzerland, Turkey, United Arab Emirates, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2256-2023) 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 August 9, 2023. 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.