Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Acuson Cypress Echocardiography System. Imaging System

FDA Recall Z-0975-03 · Posted 2003-07-02

Recalling FirmSiemans Medial Solutions USA, Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2003-04-01
Date Terminated2004-01-16
Product Quantity1540 units

Reason for Recall

software problem - loss of data

Firm Action

The recalling firm issued a letter dated 4/03 explaining the problem and the work around. A software upgarde is being provided free of charge to the customers.

Root Cause

Other

Distribution Pattern

The device was shipped to hospitals and physicians nationwide. The device was also shipped to accounts in Argentina, Australia, Austria, Belgium, Boliva, Brazil, Canada, Chile, Columbia, Costa Rica, Cypress, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, South Korea, Kuwait, Luxembourg, Malaysia, Mexico, netherlands, Norway, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021497CYPRESS ULTRASOUND SYSTEMAcuson Corp. · 2002-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑