Terminated

O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, 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 O-arm O2 Imaging System is compatible with certain image guided surgery systems.

FDA Recall Z-0927-2018 · Posted None

Recalling FirmMedtronic Navigation, Inc.-Littleton

Recall StatusTerminated

Product CodeOWB

Date Initiated2017-09-30

Date Terminated2019-05-02

Product Quantity449

Reason for Recall

During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.

Firm Action

Medtronic sent an Medical Device Safety Notice dated September 29, 2017, reminding them to follow servicing procedures. In addition, Medtronic is developing a retrofit service kit that will be installed during the next service visit for each O-arm O2 system, no later than 15 months from service kit availability. The user can continue to use the system prior to installation of the service kit. Medtronic will also implement the same changes in the manufacturing process for newly manufactured O-arm O2 systems. For further questions, please call (978) 698-6000.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV., and to the countries of : Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Luxembourg, Martinique, Mexico, Netherlands, New Zealand, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.