FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807.
- Recall number
- Z-0120-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807.
- Status
- Terminated
- Initiated
- 2008-09-02
- Posted
- 2008-11-25
- Terminated
- 2009-10-05
- Reason
- Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Root cause
- Software design
- Action
- Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
- Quantity
- 145 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 7412807. Serial numbers: 34999, 35049, 35097, 35184, 35235, 35248, 35273, 35286, 35505, 35656, 35705, 35706, 35711, 35726, 35728, 35737, 35740, 35751, 35759, 35760, 35761, 35762, 35763, 35765, 35766, 35769, 35770, 35771, 35773, 35774, 35775, 35776, 35777, 35778, 35779, 35781, 35782, 35783, 35784, 35785, 35786, 35787, 35788, 35789, 35790, 35791, 35792, 35793, 35794, 35795, 35796, 35797, 35798, 35799, 35800, 35801, 35802, 35803, 35804, 35805, 35806, 35807, 35808, 35809, 35810, 35811, 35812, 35813, 35815, 35816, 35817, 35818, 35819, 35820, 35821, 35822, 35823, 35824, 35825, 35826, 35827, 35828, 35829, 35830, 35831, 35832, 35833, 35834, 35835, 35836, 35837, 35838, 35839, 35840, 35841, 35842, 35843, 35844, 35845, 35846, 35847, 35848, 35849, 35852, 35854, 35855, 35856, 35857, 35858, 35859, 35861, 35862, 35863, 35864, 35865, 35866, 35867, 35868, 35869, 35870, 35871, 35872, 35873, 35874, 35875, 35876, 35877, 35879, 35880, 35881, 35882, 35883, 35884, 35885, 35886, 35887, 35888, 35890, 35891, 35892, 37701, 37713, 37714, 37715, and 37716.
- 510(k) numbers
- ["K010721","K021021"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28