[Recalled] SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The i
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as |
|---|---|
| Brand / manufacturer | Siemens Medical Solutions USA, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0713-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 02 October 2017 |
| EAN / barcode | 11061628 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
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
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.