Z-1088-2016Class II

Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray...

Name: Z-1088-2016 Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray...
Creator: Medtronic Navigation, Inc.
Published: 2016-01-29
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-01-29 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging... on 2016-01-29. FDA classified it as Class II and gives the reason as "Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1088-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Posted: 2016-03-08
Terminated: 2016-03-10
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 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 O-arm O2 Imaging System is compatible with certain image guided surgery systems.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic Navigation issued a Field Safety Notice dated January 29, 2016, to notify them of a hardware correction in the unit. A Medtronic service representative will service the system and arrange for an inspection of the system. This representative will properly torque the eight (8) screws if they find them to be loose. In the meantime, if noise or vibration are observed during use of the system customers should contact their Medtronic representative to report the issue. Customers with questions were instructed to call 720-890-3160. For questions regarding this recall call 978-698-6000.
Quantity in commerce: 1 unit
Distribution: Worldwide Distribution to Austria only.
Product codes and lots: Serial Number: C0936

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1088-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1088-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

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)