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Terminated

Acuson Cypress Echocardiography System

FDA Recall Z-0744-04 · Posted 2004-07-20

Recalling FirmSiemans Medial Solutions USA, Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2004-02-02
Date Terminated2004-08-19
Product Quantity46 units

Reason for Recall

software problem - mode does not appear on screen

Firm Action

The recalling firm telephoned their direct accounts to inform them of the problem and the need to modify the software. The call were made from 2/2-16/04. The modification kits were sent to consignees via express delivery.

Root Cause

Other

Distribution Pattern

The product was shipped to physicians and medical facilities in AZ, CA, CT, FL, IA, IL, NE, NV, NY, OH, TX, and WA. The product was also shipped to Australia, Brazil, Canada, Denmark, Germany, Italy, Japan, New Zealand, South Korea, and Sweden.

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.

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