Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0579-2007

AXIOM Artis MP, Angiographic x-ray system, model number 7555365

Siemens Medical Solutions USA, Inc. / initiated 2007-01-31 / Terminated

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis MP, Angiographic x-ray system, model number 7555365 on . The reason FDA records is "C-arm gantry could rapidly descend without command during use". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0579-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
AXIOM Artis MP, Angiographic x-ray system, model number 7555365
Product code
IZI System, X-Ray, Angiographic
Reason for recall
C-arm gantry could rapidly descend without command during use
FDA root cause
Other
Action
In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.
Quantity in commerce
8 units
Distribution
The products were shipped to medical facilities nationwide.
Product codes and lots
Model number 7555365 - serial numbers 57004, 57008, 57009, 57012, 57045, 57016, 57024 and 57041