Recall Z-2034-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Medtronic Navigation, Inc.
BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.
| Date | Sep 26, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii) |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Medtronic Navigation notified service engineers to retest units for compliance. |
| Quantity | 10 units |
| Distribution | CA, DC, LA, FL. IN, OH, PA, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050996 | O-ARM IMAGING SYSTEM Breakaway Imaging, LLC, May 5, 2005 |