Class 2 Device Recall Medtronic OArm 1000 Imaging System

• Date Initiated by Firm: August 30, 2018
• Create Date: October 25, 2018
• Recall Status: Terminated on June 18, 2020
• Recall Number: Z-0276-2019
• Recall Event ID: 81153
• 510(K)Number: K092564
• Product Classification: Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
• Product: O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
• Code Information: All Serial Numbers
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.-Littleton; 300 Foster St; Littleton MA 01460-2017
• For Additional Information Contact: Medtronic Technical Support; 978-698-6000
• Manufacturer Reason for Recall: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
• FDA Determined Cause: Software design
• Action: Urgent Medical Device Correction notification letters were sent to customers on 8/30/18. The letter identified the affected letter, problem and actions to be taken. All consignees will received the notification for 3.1.7 software maintenance release. Field service personnel will install the software onto the designed consignee systems.
• Quantity in Commerce: 596
• Distribution: Worldwide - US Distribution in the states: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and Puerto Rico. The products were distributed to the following foreign countries: Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OXO