FDA Device recall Z-1849-2012
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120 by Medtronic Navigation, citing software Version 3.1.1 does not meet navigational accuracy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1849-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-10-12 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Reason
Software Version 3.1.1 does not meet navigational accuracy.
Identifiers
| code_info | Serial Numbers: 125, 156, 234R. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1849-2012%22
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