Recall Z-2244-2012 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Medtronic Navigation, Inc.
Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
| Date | Aug 22, 2012 (initiated Jul 11, 2012) |
| Status | Terminated |
| Reason | A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn. |
| Root cause | Component change control |
| Action | Medtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm Imaging System. |
| Quantity | 17 units |
| Distribution | Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092564 | O-ARM IMAGING SYSTEM Medtronic Navigation, Inc. (Littleton), Jun 17, 2010 |