Reported May 1, 2024 · Ongoing
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
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 Diagnostic Ultrasound System
- REF
11503314running software version VA10A to VA10G
- Lot codes and dates
- UDI-DI04056869251264
- Serial Numbers
573 of 573 codes
560821560366560250560251560311560490560489560069560207560107560055560051560801560478560450560379560349560152561113561137560474560598560672560674560603561007560587560284561272560553560639561024561025561274560746560747562194561279561326562155562161562199562141562146562195562160562211562147560514562051560552562124560883562128560875562066560498562061562037562052
- Amount recalled
- 628
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
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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