Recalls / —

—#26730

Product

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

Affected lot / code info

Part number 7502003

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

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.

Timeline

Recall initiated

2003-02-28

Posted by FDA

2003-07-19

Terminated

2004-08-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26730. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.