Summary
The FDA issued a Class II for O-arm O2 Imaging System. Mobile X-Ray System. by Medtronic Navigation, Inc.-Boxborough. Reason: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture..
Details
Source
Device Recall
External ID
Z-2101-2025
Action Date
2025-07-16
Status
Ongoing
Category
device
Product Description
O-arm O2 Imaging System. Mobile X-Ray System.
Lot/Code Info: CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Quantity Affected: 3 units
Reason for Recall
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Distribution
US Nationwide distribution in the states of IN, MN, MS.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-27
Company
Boxborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Navigation, Inc.-Boxborough has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.-Boxborough) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc.-Boxborough have FDA actions?
Medtronic Navigation, Inc.-Boxborough has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2101-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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