Atlas FDA

MagicView 1000 and Magic View Mondo. Digital Image Communication.

FDA device recall Z-0840-03 · posted 2003-05-16 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
Action taken
Siemens informed all users via a customer safety adv isory letter sent certified mail on 7/3/2002.
Root cause
Other
Status
Terminated
Product code
LMD
Quantity affected
159 units
Distribution
Units were distributed to hospitals and clinics throughout the nation. There are 11 government hospitals.
Date initiated
2003-07-03
Date posted
2003-05-16
Date terminated
2006-10-03
Location
Malvern, PA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE (K935694)Siemens Medical Solutions USA, Inc.1994-03-07