FDA Recall
Terminated
MagicView 1000 and Magic View Mondo. Digital Image Communication.
Recall: Z-0840-03
·
Initiated July 3, 2003
Recall
- Recall Number
- Z-0840-03
- Event Number
- 26057
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- LMD
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 3, 2003
- Posted
- May 16, 2003
- Terminated
- October 3, 2006
- Address
- 51 Valley Stream Parkway, Malvern, PA, 19355
Description
MagicView 1000 and Magic View Mondo. Digital Image Communication.
Reason
Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
Action
Siemens informed all users via a customer safety adv isory letter sent certified mail on 7/3/2002.
Distribution
Units were distributed to hospitals and clinics throughout the nation. There are 11 government hospitals.
Quantity
159 units