Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 30, 2023
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.
Ground cable installed incorrectly.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Navigation, Inc.-Littleton recalled The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D … - a moderate-severity action.
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D … was recalled by Medtronic Navigation, Inc.-Littleton in August 30, 2023. Reason: Ground cable installed incorrectly.. Check the official notice for the remedy. Verify recall #Z-2449-2023 with the FDA Devices before acting.
The recall
Medtronic Navigation, Inc.-Littleton issued this moderate-severity FDA Devices recall-Ground cable installed incorrectly..
- Moderate
- severity level
- 28 units
- affected scope
- Class II
- classification
- August 30, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2449-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2449-2023) was formally reported on August 30, 2023, with the manufacturer initiating the action on July 25, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Navigation, Inc.-Littleton is listed as the recalling firm, operating out of Littleton, MA. Federal records list the affected scope as 28 units.
The documented reason for this recall is: Ground cable installed incorrectly. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
28 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Ground cable installed incorrectly.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2449-2023 |
| Date reported | August 30, 2023 |
| Date initiated | July 25, 2023 |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Firm location | Littleton, MA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2449-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Navigation, Inc.-Littleton. Units affected: 28 units.
Why was this product recalled? ▼
Ground cable installed incorrectly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2023. Severity: Moderate. Recall number: Z-2449-2023.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2449-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 30, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.