Reported Oct 2, 2024 · Ongoing
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select…
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 Juniper 1.01.52.02.5 Diagnostic Ultrasound Systems
- REF
11335791with software. ACUSON Juniper Select 2.02.5 Diagnostic Ultrasound Systems
- REF11653093, with software
- Lot codes and dates
- 11335791
- UDI-DI
04056869152059: 1.0/VA10G and prior1.5/ VB10H and prior2.0/ VB11C and prior2.5/ VB30D and prior. 11653093
- UDI-DI
04056869957357: 2.0/ VB11C and prior2.5/ VB30D and prior
- Amount recalled
- 7022
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.
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.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.