Recall record at a glance
| Official record | Z-1308-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Apr 1, 2015 |
| Recall initiation date | Mar 9, 2015 |
| Quantity | 132 |
| Location | Malvern, PA, United States |
Official 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.
Why the product was recalled
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.
Distribution information
Nationwide Distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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