Medtronic Navigation, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2244-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 11, 2012

Date Posted: August 29, 2012

Recall Number: Z-2244-2012

Event ID: 62571

Reason for Recall:

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

Status: Terminated

Product Quantity: 17 units

Code Information:

Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.

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.

Voluntary or Mandated:

Voluntary: Firm initiated