Reported Mar 9, 2016 · Terminated
PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies Inc.
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: Novadaq Technologies Inc. · 8329 Eastlake Dr Unit 101 · Burnaby, N/A · N/A
Is this the product you have?
- PINPOINT Endoscopic Fluorescence Imaging System
- Lot codes and dates
- Rev. J, Rev. K, Rev. L and Rev
- M Model NumberPC9000
- Amount recalled
- 110 units
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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