Recall Z-3009-2011 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system
| Date | Aug 11, 2011 (initiated Jun 29, 2011) |
| Status | Terminated |
| Reason | When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240: |
| Root cause | Labeling False and Misleading |
| Action | Siemens sent a "Customer Safety Advisory Notice" letters to all affected users dated June 13, 2011. The letter identified the product, the problem, and the actions to be taken. Siemens included in the notice an addendum to the instruction for use to each system and request customers to take special attention. Customers were instructed to place the Safety Notice in the System's instruction for use. All appropriate personnel should be notified of the correction notice. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the |
| Quantity | 18 |
| Distribution | Nationwide Distribution (USA) including the states of: CA, CT, FL, KS, MN, MO, NJ, NY, NC, PA, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040675 | AXIOM ARTIS U Siemens Medical Systems, Inc., Jun 10, 2004 |