—#134534

Product

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.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K121434
Affected lot / code info: model numbers: 10432914, 10432915, 10684331, 10684332, 10684333, 10684334 with serial numbers: 45398 45788 59092 60099 41953 45805 52255 45812 52250 52171 52264 41980 41448 60092 41727 60038 60062 59071 59065 60061 60082 62032 41548 52168 59032 62014 60086 57118 52108 41628 60070 45249 62027 41699 41701 59090 60060 60052 41903 52082 41473 45537 41749 41457 42060 41383 41769 45778 62018 45628 52200 42033 52135 52195 41317 41529 45371 57060 41862 59101 52150 52240 52128 41608 41624 42012 45160 45387 45603 45526 41476 45155 52251 41746 62020 41503 59120 62024 59096 62025 41897 59109 45681 41362 60053 60055 59087 60085 41819 59116 62031 52172 52057 52153 45623 59112 41844 41874 59104 45850 41621 52192 60054 41595 45667 41353 60063 57254 41556 60079 45408 41654 52021 52072 57146 45239 59035 59076 41629 41802 41952 45230 45251 41979 45237 45205 45694 41671 45507 41389 41295 60091

Why it 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

A Customer Safety Advisory Notice, dated March 6, 2015, was sent to end users to inform them of the potential issue and what measures were being taken to mitigate possible risks.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-03-09
Posted by FDA: 2015-03-20
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134534. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.