MAGNETOM systems Aera/Skyra/Avanto/Verio with software recall
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce…
Why was MAGNETOM systems Aera/Skyra/Avanto/Verio with software 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 132
- Distribution
- Nationwide Distribution.
- Recall date
- April 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)