Atlas FDA

Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIM

FDA device recall Z-0850-2008 · posted 2008-02-19 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
Door Hinge failures; loose or falling off (Stationary Structure Doors)
Action taken
Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits.
Root cause
Component design/selection
Status
Terminated
Product code
IYE
Quantity affected
1,284 total for recalls Z-0850-0852-2008
Distribution
Worldwide- USA including the states of Missouri, Georgia, Delaware, Texas, Ohio, Alabama, Kentucky, Florida, California, North Carolina, New Jersey, New York, Illinois, Pennsylvania, Colorado, Tenness
Date initiated
2007-07-27
Date posted
2008-02-19
Date terminated
2011-04-29
Location
Concord, CA

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Related 510(k) clearances

RecordFirmDate
PRIMUS (K993425)Siemens Medical Solutions USA, Inc.1999-11-26