Reported Oct 2, 2024 · Ongoing
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 22010 Se 51st St · Issaquah, WA · 98029-7298
Is this the product you have?
- ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems
- REF11503314, with software
- Lot codes and dates
- 11503314
- UDI-DI
04056869251264: 1.0/Software VA10G and prior2.0/Software VA20K and prior
- Amount recalled
- 1990
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
This product could cause temporary or reversible health problems — stop using it.
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