Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2018
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the ne…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Navigation, Inc.-Littleton recalled Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: … - a moderate-severity action.
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: … was recalled by Medtronic Navigation, Inc.-Littleton in November 14, 2018. Reason: O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Ac…. Check the official notice for the remedy. Verify recall #Z-0404-2019 with the FDA Devices before acting.
The recall
Medtronic Navigation, Inc.-Littleton issued this moderate-severity FDA Devices recall-O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Ac….
- Moderate
- severity level
- 641 units
- affected scope
- Class II
- classification
- November 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0404-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0404-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on September 17, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Navigation, Inc.-Littleton is listed as the recalling firm, operating out of Littleton, MA. Federal records list the affected scope as 641 units.
The documented reason for this recall is: O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide Foreign: AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CANADA CHILE COLOMBIA DENMARK FINLAND FRANCE GERMANY HR ICELAND INDIA IRELAND ISRAEL ITALY JAPAN …. 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
641 units
Related Recalls
6
3 from same agency
Product description
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Reason for recall
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0404-2019 |
| Date reported | November 14, 2018 |
| Date initiated | September 17, 2018 |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Firm location | Littleton, MA |
| Affected scope | 641 units |
| Distribution | Worldwide Distribution - US Nationwide Foreign: AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CANADA CHILE COLOMBIA DENMARK FINLAND FRANCE GERMANY HR ICELAND INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KOREA, REPUB… |
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-0404-2019) 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? ▼
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R. Recalled by Medtronic Navigation, Inc.-Littleton. Units affected: 641 units.
Why was this product recalled? ▼
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0404-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide Foreign: AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CANADA CHILE COLOMBIA DENMARK FINLAND FRANCE GERMANY HR ICELAND INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KOREA, REPUBLIC OF LUXEMBOURG MARTINIQUE MEXICO NETHERLANDS NEW ZEALAND POLAND PORTUGAL PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED ARAB EMIRATES UNITED KINGDOM.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0404-2019) 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 November 14, 2018. 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.