Z-0973-2014Class II

Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging...

Name: Z-0973-2014 Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging...
Creator: Medtronic Navigation, Inc.
Published: 2013-07-25
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2013-07-25 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D... on 2013-07-25. FDA classified it as Class II and gives the reason as "Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0973-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Posted: 2014-02-28
Terminated: 2019-04-17
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Medtronic Navigation Inc. issued Notiifcation on 3/4/14 and included thee errata sheet to all affected customers updating the missing and incorrect information and ensure that labeling is now in compliance with 21 CFR Part 1020.30(h). This will be followed by a software update that contains the same information on the errata sheet, which serves to correct the electronic version of the Instructions for Use. The paper errata sheet will be sent via traceable means and the software upgrade will be performed by Medtronic Service either through remote access or by site visit of Medtronic service personnel. For further questions please call (978) 698-6000.
Quantity in commerce: 449 in US
Distribution: USA (nationwide) Distribution
Product codes and lots: Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0973-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0973-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-02-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)