Z-2101-2025Class II

O-arm O2 Imaging System. Mobile X-Ray System

Name: Z-2101-2025 O-arm O2 Imaging System. Mobile X-Ray System
Creator: Medtronic Navigation, Inc.-Boxborough
Published: 2025-05-27
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2025-05-27 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc.-Boxborough began a recall of O-arm O2 Imaging System. Mobile X-Ray System on 2025-05-27. FDA classified it as Class II and gives the reason as "A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2101-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-27
Posted: 2025-07-09
Recalling firm: Medtronic Navigation, Inc
Product: O-arm O2 Imaging System. Mobile X-Ray System.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An URGENT: MEDICAL DEVICE CORRECTION notice dated 5/27/25 was mailed to consignees. In the notice consignees are instructed to discontinue use of affected systems until it can be serviced by Medtronic personnel; a copy of the recall notification is to be posted with the system until the issue has been resolved. A Medtronic Field Service Engineer will contact consignees to schedule a visit to inspect affected systems and implement any corrections needed. Consignees are to complete and return the provided Customer Confirmation Form and forward the recall notification to all users and facilities to which product was further distributed. Consignees with any questions can contact Technical Services for help by phone at 1-888-826-5603 or by email at [email protected].
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of IN, MN, MS.
Product codes and lots: CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2101-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2101-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-09

Product code OWB

K240465Class IIO-arm O2 Imaging SystemMedtronic Navigation, Inc. / cleared 2024-06-21

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)