—#111068

Product

Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.

FDA product code: OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K092564
Affected lot / code info: Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.

Why it was recalled

A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.

Root cause (FDA determination)

Component change control

Action the firm took

Medtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm Imaging System.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.

Timeline

Recall initiated: 2012-07-11
Posted by FDA: 2012-08-22
Terminated: 2016-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.