Food, drugs, devices › Medtronic Navigation, Inc.-Littleton
Device recall: Medtronic Navigation O-arm 02 surgical x-ray imaging system
Medtronic Navigation, Inc.-Littleton (Littleton, MA) initiated this device recall on 17 Mar 2016; FDA lists 1 product record under event 74158, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 6 Apr 2021. Initiation: voluntary: firm initiated. Medtronic Navigation, Inc.-Littleton has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Navigation, Inc.-Littleton, Littleton, MA.
Reason for recall
"Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h)."
Distribution
"Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2083-2016 | Medtronic Navigation O-arm 02 surgical x-ray imaging system | US - 63 | Class II | Terminated | 13 Jul 2016 |
Context
Other enforcement events for Medtronic Navigation, Inc.-Littleton
All 11 events for Medtronic Navigation, Inc.-Littleton
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.