Z-2244-2012Class II

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

Name: Z-2244-2012 Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120...
Creator: Medtronic Navigation, Inc.
Published: 2012-07-11
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2012-07-11 / Terminated

FDA source

Medtronic Navigation, Inc. began a recall of 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 on 2012-07-11. FDA classified it as Class II and gives the reason as "A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2244-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Posted: 2012-08-22
Terminated: 2016-06-06
Recalling firm: Medtronic Navigation, Inc
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.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.
FDA root cause: Component change control
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.
Quantity in commerce: 17 units
Distribution: 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.
Product codes and lots: Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2244-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2244-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-22

Product code OXO

K092564Class IIO-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) / cleared 2010-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)