Axiom Artis X-Ray System using software version VB11D or VB20B
FDA device recall Z-0796-05 · posted 2005-05-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Live display in exam room may sporadically stop working although the display in the control room remains fully operational
- Action taken
- The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 295 units
- Distribution
- The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV.
- Date initiated
- 2005-04-11
- Date posted
- 2005-05-03
- Date terminated
- 2006-08-23
- 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 |
|---|---|---|
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |