Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1029-03

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

Siemens Medical Solutions USA, Inc. / initiated 2003-02-28 / Terminated / root cause: software

Siemens Medical Solutions USA, Inc began a recall of Magic View 1000U, version VE40A. Digital Image Communication System on . The reason FDA records is "software issue. New examinations may not be saved properly and the examination may be lost". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1029-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Magic View 1000U, version VE40A. Digital Image Communication System
Reason for recall
software issue. New examinations may not be saved properly and the examination may be lost.
Root cause tag
software
FDA root cause
Other
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.
Quantity in commerce
49 units
Distribution
The product was shipped to medical facilities in AL, CA, CO, FL, NE, IL, IN, MI, MN, NJ, NY, OH, PA, TN, and VA.
Product codes and lots
Part number 7502003