ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 11335791, UDI-DI: 04056869152059: 1.0/VA10G and prior, 1.5/ VB10H and prior , 2.0/ VB11C and prior, 2.5/ VB30D and prior. 11653093, UDI-DI: 04056869957357: 2.0/ VB11C and prior, 2.5/ VB30D and prior.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc.
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Product Codes/Lot Numbers:
11335791, UDI-DI: 04056869152059: 1.0/VA10G and prior, 1.5/ VB10H and prior , 2.0/ VB11C and prior, 2.5/ VB30D and prior. 11653093, UDI-DI: 04056869957357: 2.0/ VB11C and prior, 2.5/ VB30D and prior.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3215-2024
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