Z-2449-2023Class II

The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult...

Name: Z-2449-2023 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult...
Creator: Medtronic Navigation, Inc.-Littleton
Published: 2023-07-25
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2023-07-25 / Open, Classified

FDA source

Medtronic Navigation, Inc.-Littleton began a recall of The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater... on 2023-07-25. FDA classified it as Class II and gives the reason as "Ground cable installed incorrectly". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2449-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-25
Posted: 2023-08-24
Recalling firm: Medtronic Navigation, Inc
Product: The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Ground cable installed incorrectly.
FDA root cause: Under Investigation by firm
Action: Customers were sent recall notification via UPS 2-day delivery on 7/25/2023. The recall notification informs consignees they may continue to use the device per facility protocol; there is no risk to the patient or user when system panels remain intact. Consignees are to inform all personnel in all care environments in with the recalled device is used about the provided Medical Device Correction Notice and to post copies of the notification in a prominent location to maintain awareness until the issue is resolved by a Medtronic Field Service Engineer. Consignees are to complete and return the provided customer confirmation form via email to [email protected]. If consignees are aware of any incidents related to this recall, they are to contact Technical Support immediately by phone at 1-888-826-5603 or by mail at [email protected]. Medtronic will schedule a service visit to correct this issue but if consignees have any questions regarding this issue in the interim, contact Technical Services for help at 1-800-595-9709 (US) or 1-700-890-3160 (OUS) and reference FA1351.
Quantity in commerce: 28 units
Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KY, MI, MO, NC, NV, OH, TN, UT, VA, & WA. The countries of Canada, Ireland, Poland, Russian Federation, Switzerland, & Viet Nam.
Product codes and lots: Model No. BI70002000; UDI-DI: 00763000074128, 00763000081041, 00763000355555, 00763000496784, 00763000542801, 00763000616434, 00763000616526, 00763000616564; Serial No. C2786, C2841, C2781, C2624, C2659, C2660, C2665, C2672, C2708, C2723, C2735, C2760, C2774, C2775, C2779, C2798, C2814, C2823, C2873, C2918, C2968, C3290, C3363, C3188, C3322, C3387, C3404, and C3418.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2449-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2449-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)