Atlas FDA

Magnetom Trio magnetic resonance imaging

FDA device recall Z-0225-2007 · posted 2006-11-29 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
Possible excessive RF exposure/may burn
Action taken
The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions MR038/06/S. The letter informs customers of the potential issue and instructs them not to use the involved coils until this issue can be corrected.
Root cause
Other
Status
Terminated
Product code
LNH
Quantity affected
12 units
Distribution
Nationwide.
Date initiated
2006-10-12
Date posted
2006-11-29
Date terminated
2008-04-23
Location
Malvern, PA

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Related 510(k) clearances

RecordFirmDate
MAGNETOM TRIO A TIM SYSTEM (K050200)Siemens Medical Solutions USA, Inc.2005-02-28