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Terminated

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 Recall Z-1998-2010 · Posted 2010-07-13

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-05-10
Date Terminated2011-10-07
Product Quantity221

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060344O-ARM IMAGING SYSTEMBreakaway Imaging, LLC · 2006-03-29K050996O-ARM IMAGING SYSTEMBreakaway Imaging, LLC · 2005-05-05

Official Source

View FDA Recall →

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

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