AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems devel
FDA device recall Z-2587-2014 · posted 2014-09-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
- Action taken
- Siemens sent an Important Safety Information letter dated June 5, 2014, to affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to observe this safety notice and comply with the corresponding measures until the update has been fully completed.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 1067
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2014-06-05
- Date posted
- 2014-09-24
- Date terminated
- 2015-04-06
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |