Recall Z-0928-2018 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Medtronic Navigation, Inc.-Littleton
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SY
| Date | Jan 25, 2018 |
| Status | Terminated |
| Reason | Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin. |
| Root cause | Software design |
| Action | Medtronic sent an Urgent Medical Device Correction letter to their customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a local service representative will contact you to install the update. For questions contact Medtronic Technical Support at 1-800-595-9709. |
| Quantity | 253 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Puerto Rico. Distributed in Algeria, Australia, Chile, China, Czech Republic, F |
| 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 |