Recall Z-2083-2016— Medtronic Navigation, Inc.-Littleton
Class II · Terminated
Class II FDA medical device recall by Medtronic Navigation, Inc.-Littleton, initiated 2016-03-17, terminated 2021-04-06. It names one FDA 510(k) clearance: K151000. Product: Medtronic Navigation O-arm 02 surgical x-ray imaging system. Reason: 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)..
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-17
- Terminated
- 2021-04-06
- Firm location
- Littleton, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic Navigation O-arm 02 surgical x-ray imaging system
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.