FDA Devices recall · Reported April 1, 2015
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. Th
The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation…
Siemens Medical Solutions USA, Inc recalled MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use… - a moderate-severity action.
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use… was recalled by Siemens Medical Solutions USA, Inc in April 1, 2015. Reason: The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outp…. Check the official notice for the remedy. Verify recall #Z-1308-2015 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outp….
- Moderate
- severity level
- 132 units
- affected scope
- Class II
- classification
- April 1, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1308-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
Reason for recall
The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1308-2015 |
| Date reported | April 1, 2015 |
| Date initiated | March 9, 2015 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 132 |
| Distribution | Nationwide 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-1308-2015) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026