Siemens ACUSON Origin ICE ultrasound recalled for software issue
A software issue in ACUSON Origin ICE ultrasound imaging systems may cause the Color Doppler setting to activate unintentionally. This setting has not received FDA clearance. The unintended activation could cause the system to crash or become unresponsive.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Contact Siemens Medical Solutions USA, Inc. about the software issue and how to address it. The notice does not specify a remedy.
- Check whether your system runs ACUSON Origin ICE software version 4.0 (VD10A).
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ACUSON Orgin ICE Ultrasound Imaging System REF: 11669400
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 4 products — see all of them.
Details
- Units affected
- 0 systems
- Illnesses reported
- None reported
- Manufactured in
- 22010 Se 51st St, Issaquah, Washington, United States
- Classification
- Class II
- Recall number
- Z-0393-2027
In the FDA's words
- Description
- ACUSON Orgin ICE Ultrasound Imaging System REF: 11669400 A software issue identified in the ultrasound system may result in the unintended activation of the Color Doppler setting, which has not received FDA clearance. This unintended activation could cause the system to crash or become unresponsive. ACUSON Origin sys Ice systems with software version 4.0 (VD10A) Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, KY, NC, TX and the countries of Germany, Italy, India. Affected quantity: 0 systems
- Hazard
- A software issue identified in the ultrasound system may result in the unintended activation of the Color Doppler setting, which has not received FDA clearance. This unintended activation could cause the system to crash or become unresponsive.
4 products in this recall
Siemens ACUSON ultrasound systems recalled for unintended Color Doppler activation
Siemens is recalling four ACUSON ultrasound imaging systems: ACUSON Orgin, ACUSON Orgin ICE, ACUSON Sequoia and ACUSON Sequoia Select. A software issue may cause the Color Doppler setting to activate unintentionally. That setting has not received FDA clearance, and the activation could cause the system to crash or become unresponsive. The recall was distributed in the US states of CA, CT, KY, NC and TX and in Germany, Italy and India.
The agency lists each product separately. Check every one you might have.
- ACUSON Orgin Ultrasound Imaging System
REF: 11668590Z-0392-2027 · 56 systems
- ACUSON Orgin ICE Ultrasound Imaging System
REF: 11669400 (this page)Z-0393-2027 · 0 systems
- ACUSON Sequoia Ultrasound Imaging System
REF: 11148775Z-0394-2027 · 37 systems
- ACUSON Sequoia Select Ultrasound Imaging System
REF: 11658635Z-0395-2027 · 0 systems