| Date Initiated by Firm | May 27, 2025 |
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| Date Posted | July 09, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2101-2025 |
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| Recall Event ID |
97045 |
| 510(K)Number | K240465 |
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| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | O-arm O2 Imaging System. Mobile X-Ray System. |
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| Code Information |
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019. |
| FEI Number |
3004785967
|
Recalling Firm/
Manufacturer |
Medtronic Navigation, Inc.-Boxborough
200 Beaver Brook Road
Boxborough MA 01719
|
| For Additional Information Contact | Christine Steward
269-377-2557 |
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Manufacturer Reason
for Recall | A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 rs.navtechsupport@medtronic.com. |
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| Quantity in Commerce | 3 units |
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| Distribution | US Nationwide distribution in the states of IN, MN, MS. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OWB
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