Z-2083-2016Class II

Medtronic Navigation O-arm 02 surgical x-ray imaging system

Name: Z-2083-2016 Medtronic Navigation O-arm 02 surgical x-ray imaging system
Creator: Medtronic Navigation, Inc.-Littleton
Published: 2016-03-17
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-03-17 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Navigation, Inc.-Littleton began a recall of Medtronic Navigation O-arm 02 surgical x-ray imaging system on 2016-03-17. FDA classified it as Class II and gives the reason as "Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR...". 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-2083-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-17
Posted: 2016-07-06
Terminated: 2021-04-06
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic Navigation O-arm 02 surgical x-ray imaging system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Medtronic planned action to bring device into Compliance: 1. You will contact customers and provide an Errata sheet to them updating the missing and incorrect information. 2. Medtronic field service personnel will perform radiation output measurements via validated procedures to attain compliance with 21CRF part 1020.32(k)(6). 3. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For questions call (800)-595-9709.
Quantity in commerce: US - 63
Distribution: Nationwide Distribution
Product codes and lots: model number BT-700-02000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2083-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2083-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code OWB

K151000Class IIO-Arm O2 Imaging SystemMedtronic, Inc. / cleared 2015-08-06

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)