Fluorescence Imaging Procedure Kit recall
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive…
Why was Fluorescence Imaging Procedure Kit recalled?
The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.
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?
PN 950156-01
- Product
- Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 1532 total both devices
- Distribution
- Nationwide Distribution.
- Recall date
- December 31, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)