FrameLink. The software application is sent in CD recall: Software Issue
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The…
Why was FrameLink. The software application is sent in CD recalled?
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
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 9733986-02 . All lot numbers manufactured by Medtronic Navigation are affected.
- Product
- FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The…
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 27 in total
- Distribution
- Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.
- Recall date
- August 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)