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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
