ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 04056869251264. Systems with software version prefix VA20.
- 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 a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Product Codes/Lot Numbers:
UDI-DI: 04056869251264. Systems with software version prefix VA20.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2582-2023
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