[Recalled] ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F — Due to adverse events received by the firm for left atrial perforations and Atr… | FDA 2020-05-22

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Siemens Medical Solutions USA, Inc.

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• e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. — Class II
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• Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.