FDA Recall
Terminated
Magic View 1000U, version VE40A. Digital Image Communication System
Recall: Z-1029-03
·
Initiated February 28, 2003
Recall
- Recall Number
- Z-1029-03
- Event Number
- 25928
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 28, 2003
- Posted
- July 19, 2003
- Terminated
- August 25, 2004
- Address
- 51 Valley Stream Parkway, Malvern, PA, 19355
Description
Magic View 1000U, version VE40A. Digital Image Communication System
Reason
software issue. New examinations may not be saved properly and the examination may be lost.
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.
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.
Quantity
49 units