Recall Z-0927-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic Navigation, Inc.-Littleton
O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures a
| Date | Sep 30, 2017 |
| Status | Terminated |
| Reason | During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician. |
| Root cause | Employee error |
| Action | Medtronic sent an Medical Device Safety Notice dated September 29, 2017, reminding them to follow servicing procedures. In addition, Medtronic is developing a retrofit service kit that will be installed during the next service visit for each O-arm O2 system, no later than 15 months from service kit availability. The user can continue to use the system prior to installation of the service kit. Medtronic will also implement the same changes in the manufacturing process for newly manufactured O-arm O2 systems. For further questions, please call (978) 698-6000. |
| Quantity | 449 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV., and to the countries of : Australia, Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151000 | O-Arm O2 Imaging System Medtronic, Inc., Aug 6, 2015 |