Reported Jul 13, 2016 · Terminated
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Medtronic Navigation, Inc.-Littleton
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc.-Littleton · 300 Foster Street · Littleton, MA · 01460-2017
Is this the product you have?
- Medtronic Navigation O-arm 02 surgical x-ray imaging system
- Lot codes and dates
- model number BT-700-02000
- Amount recalled
- US - 63
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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