Siemens MAGNETOM MRI Systems Recalled for Gradient Output Supervision Defect
Siemens Medical Solutions is recalling 132 MAGNETOM MRI systems because a defect in gradient output supervision could allow outputs to exceed safety limits, potentially causing peripheral nerve stimulation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (peripheral nerve stimulation) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 132 MAGNETOM systems (Aera, Skyra, Avanto, and Verio models) equipped with syngo MR D13A software. These magnetic resonance diagnostic devices are indicated for producing cross-sectional and spectroscopic images to assist in diagnosis. The affected units were distributed nationwide.
The recall was initiated because the gradient output supervision on these systems was permanently turned off. This defect means that gradient outputs could exceed the safety limits established by IEC60601-2-33. If these limits are exceeded, peripheral nerve stimulation could occur in patients.
Healthcare facilities and consumers should contact Siemens Medical Solutions USA, Inc. for further information regarding the recall and corrective actions. The specific model numbers and serial numbers affected are listed in the official recall documentation.
The recalled product
- 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 inter
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 132
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- model numbers: 10432914
- 10432915
- 10684331
- 10684332
- 10684333
Distribution
Distributed nationwide across the United States.
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