Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 28, 2015
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associat…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc recalled Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho… - a moderate-severity action.
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho… was recalled by Siemens Medical Solutions USA, Inc in January 28, 2015. Reason: Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 …. Check the official notice for the remedy. Verify recall #Z-0994-2015 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 ….
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- January 28, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0994-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0994-2015) was formally reported on January 28, 2015, with the manufacturer initiating the action on December 15, 2014. 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 Malvern, PA. Federal records list the affected scope as 11.
The documented reason for this recall is: Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may b… Distribution data in the federal record shows the product reached: US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.. 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
11
Related Recalls
6
3 from same agency
Product description
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Reason for recall
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0994-2015 |
| Date reported | January 28, 2015 |
| Date initiated | December 15, 2014 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 11 |
| Distribution | US Distribution to states of: ID, IL, MI, MN, MO, ND and PA. |
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-0994-2015) 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? ▼
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 11.
Why was this product recalled? ▼
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 28, 2015. Severity: Moderate. Recall number: Z-0994-2015.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: ID, IL, MI, MN, MO, ND and PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0994-2015) 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 January 28, 2015. 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.