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

Recall Z-1959-2015 — ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Pe

U.S. FDA — Device Enforcement · United States · 2015-05-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1959-2015
Date of alert: 2015-05-29
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): 10433816

Reported risk: When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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