Medtronic Navigation O-arm 02 surgical x-ray imaging recall: Labeling Error
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Why was Medtronic Navigation O-arm 02 surgical x-ray imaging 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
model number BT-700-02000
- Product
- Medtronic Navigation O-arm 02 surgical x-ray imaging system
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Quantity
- US - 63
- Distribution
- Nationwide Distribution
- Recall date
- July 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)