—#95240

Product

Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Numbers: 9732719,9733346,81-700-00027, 81-700-00027R, 81700- 00027-100, 81-700-00027-1 OOR, 81-700-00027-120, 81-700-00027-120R, 81700-00027-230, 81-700-00027-230R, 81-700-00027GER, 81-700-00027GERR Intended use: Designed for 2D fluoroscopic and 3D imaging and is intended to be used by a physician benefits from 2D and 3D information of anatomic structures with high x-ray attenuation such as bony and metallic objects.

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K092564
Affected lot / code info: All Units distributed from June 2006 through September 2010

Why it was recalled

Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Medtronic Navigation sent all consignees/customers an "Urgent Field Safety Notice" letter dated October 15, 2010. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review and follow the attached information that describes the process to properly detect and proactively manage cable wear; to ensure that the door is completely open when positioning the patient into or removing them from the gantry and when placing the O-ARM Imaging System Tube Drape (BI-900-00003) onto the unit, and report any visual or audible (cracking noise) wear of the cable to Medtronic Representative ASAP. Note: A Medtronic Representative will be contacting the customers within the coming weeks to schedule a time to inspect the current condition of the cable, explain and train the customers on the recommended workflow and inspection procedure and place a permanent label on their O-ARM Imaging System to reinforce these actions. If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or 720-890-3200.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 300 Foster St, Littleton, Massachusetts 01460-2017

Distribution

Distribution pattern: Worldwide distribution: USA including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, and WI; and countries including: Canada, Austria, Australia, Belgium, Brazil, Libya, South Africa, India, Japan, Singapore South Korea, Haiti, Kuwait, Saudi Arabia, Turkey, UAE, Germany, Netherlands, Great Britain, Italy, Poland, Netherlands, Spain,Sweden, and Switzerland.

Timeline

Recall initiated: 2010-10-15
Posted by FDA: 2010-11-23
Terminated: 2012-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.