Recalls / —

—#91521

Product

O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging.

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K050996, K060344

Affected lot / code info

Product Catalog Number: 9732719, 9733346, BI-700-00027-100, BI-70000027-120, BI-700-00027-230

Why it was recalled

The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Medtronic, Inc., sent an "Urgent Field Safety Notice" letter dated May 10, 2010, to all custmers. The letter describes the product, problem and actions to be taken by customer. The firm recommended that the users of the O-Arm Imaging System reveiw the information provided to ensure patient safety remains uncompromised during use of the product. The customers were instructed to discontinue use and contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200, if the image is not updating as expected. A Medtronic Navigation representative will be contacting you within the coming months to schedule a time to evaluate and service the potentially affected components within your system. A service visit will also be scheduled starting November 2010 to update your system with a software based solution that will prevent this issue from occuring. 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 (702) 890-3200.

Recalling firm

Firm

Medtronic Navigation, Inc.

Address

300 Foster St, Littleton, Massachusetts 01460-2017

Distribution

Distribution pattern

Worldwide distribution: USA and countries of Germany, Singapore, South Africa, Poland, Libya, Belgium, Switzerland, Turkey, Italy, Denmark, France, Spain, Finland, Czech Republic, Ireland, Slovakia, the NetherLands, Austria, UAE, Kuwait, Israel, Australia, Sweden, Canada, South Korea, Japan and India.

Timeline

Recall initiated

2010-05-10

Posted by FDA

2010-07-13

Terminated

2011-10-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #91521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.