AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system.
FDA device recall Z-2233-2010 · posted 2010-08-16 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion.
- Action taken
- Siemens has issued an "Urgent Field Safety Notice: Customer Safety Information to consignees with Update Instructions AX033/10/S. This letter informed customers of the issue, and provides an Addendum to the User Manual. The Update Instructions describe the process for installation of an additional clamping mechanism provided by Siemens into the existing system, which will be activated if the gearbox is damaged. If activated, the clamping machanism will prevent the C-arm from tilting away, stop regular operation, and alert the operator to check the system and repair the gearbox damage.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 131 units
- Distribution
- Nationwide distribution: States of AL, AZ, CA, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, and WY.
- Date initiated
- 2010-07-13
- Date posted
- 2010-08-16
- Date terminated
- 2012-07-05
- 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 |
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |