[Recalled] ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Tr
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal |
|---|---|
| Brand / manufacturer | Siemens Medical Solutions USA, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1584-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 July 2012 |
| EAN / barcode | 10433816 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: In certain situations, loss of post exercise images can occur in Stress Echo.
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.
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