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Terminated

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 Recall Z-2244-2012 · Posted 2012-08-22

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeOXO
Date Initiated2012-07-11
Date Terminated2016-06-06
Product Quantity17 units

Reason for Recall

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

Firm Action

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.

Root Cause

Component change control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092564O-ARM IMAGING SYSTEMMedtronic Navigation, Inc. (Littleton) · 2010-06-17

Official Source

View FDA Recall →

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

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