Medtronic Navigation, Inc.: 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.

Recall number

Z-0447-2011

Recalling firm

Medtronic Navigation, Inc.

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.

Status

Terminated

Initiated

2010-10-15

Posted

2010-11-23

Terminated

2012-06-04

Reason

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

Equipment maintenance

Action

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.

Quantity

244 units

Distribution

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.

Lot, serial or model codes

All Units distributed from June 2006 through September 2010

510(k) numbers

["K092564"]

PMA numbers

not on file

Product code

IZL

Firm FEI

3004785967

Firm city

Littleton

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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