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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic OArm 1000 Imaging System

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  Class 2 Device Recall Medtronic OArm 1000 Imaging System see related information
Date Initiated by Firm August 30, 2018
Create Date October 25, 2018
Recall Status1 Terminated 3 on June 18, 2020
Recall Number Z-0277-2019
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 OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230

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 2		 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 total
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 and Original Applicant = MEDTRONIC NAVIGATION, INC. (LITTLETON)
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