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Terminated

Magic View 1000U, version VE40A. Digital Image Communication System

FDA Recall Z-1029-03 · Posted 2003-07-19

Recall StatusTerminated
Date Initiated2003-02-28
Date Terminated2004-08-25
Product Quantity49 units

Reason for Recall

software issue. New examinations may not be saved properly and the examination may be lost.

Firm Action

The recalling firm has issued a letter to their field service representative dated 2/28/02. The letter is entitled Safety Modification CN002/03/S which instructs the recalling firm's service engineers to visit each affected site and correct the software problem. A set of instructions were sent with the letter.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities in AL, CA, CO, FL, NE, IL, IN, MI, MN, NJ, NY, OH, PA, TN, and VA.

Official Source

View FDA Recall →

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

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