Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2582-2023 — ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

U.S. FDA — Device Enforcement · United States · 2023-07-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2582-2023
Date of alert
2023-07-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04056869251264
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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