Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 31, 2023
Luminos Agile Max (VE10, VF10, VF11)
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate rela…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc recalled Luminos Agile Max (VE10, VF10, VF11) - a moderate-severity action.
Luminos Agile Max (VE10, VF10, VF11) was recalled by Siemens Medical Solutions USA, Inc in May 31, 2023. Reason: Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact…. Check the official notice for the remedy. Verify recall #Z-1479-2023 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact….
- Moderate
- severity level
- 704 units
- affected scope
- Class II
- classification
- May 31, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1479-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1479-2023) was formally reported on May 31, 2023, with the manufacturer initiating the action on November 23, 2022. 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 Malvern, PA. Federal records list the affected scope as 704 units in the United States (1945 units worldwide).
The documented reason for this recall is: Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, acco… Distribution data in the federal record shows the product reached: US Nationwide - Worldwide Distribution. 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
704 units in the United States (1945 units worldwide)
Related Recalls
6
3 from same agency
Product description
Luminos Agile Max (VE10, VF10, VF11)
Reason for recall
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1479-2023 |
| Date reported | May 31, 2023 |
| Date initiated | November 23, 2022 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 704 units in the United States (1945 units worldwide) |
| Distribution | US Nationwide - Worldwide Distribution |
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-1479-2023) 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? ▼
Luminos Agile Max (VE10, VF10, VF11). Recalled by Siemens Medical Solutions USA, Inc. Units affected: 704 units in the United States (1945 units worldwide).
Why was this product recalled? ▼
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Moderate. Recall number: Z-1479-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide - Worldwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1479-2023) 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 May 31, 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.