PINPOINT Endoscopic Fluorescence Imaging System recall
PINPOINT Endoscopic Fluorescence Imaging System
Why was PINPOINT Endoscopic Fluorescence Imaging System recalled?
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
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?
Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000
- Product
- PINPOINT Endoscopic Fluorescence Imaging System
- Recalling firm
- Novadaq Technologies Inc.
- Quantity
- 110 units
- Distribution
- Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
- Recall date
- March 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)