Medtronic Navigation O-arm 02 surgical x-ray imaging system
Reported: July 13, 2016 Initiated: March 17, 2016 #Z-2083-2016
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).
Details
- Recalling Firm
- Medtronic Navigation, Inc.-Littleton
- Units Affected
- US - 63
- Distribution
- Nationwide Distribution
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
Medtronic Navigation O-arm 02 surgical x-ray imaging system. Recalled by Medtronic Navigation, Inc.-Littleton. Units affected: US - 63.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2083-2016.
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