Novadaq PINPOINT Endoscopic Imaging System Recalled for Manual Error
Novadaq is recalling 110 PINPOINT Endoscopic Fluorescence Imaging Systems because the operator's manual lacks validated sterilization parameters for specific components.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a documentation error (missing sterilization parameters) rather than a direct physical defect, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Novadaq Technologies Inc. is recalling 110 units of the PINPOINT Endoscopic Fluorescence Imaging System (Model PC9000, Rev. J, K, L, and M). The recall was initiated because 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.
The affected units were distributed worldwide, including nationwide distribution in the United States (including Puerto Rico) and to Bangladesh, Canada, Hong Kong, India, and Israel. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should contact Novadaq Technologies Inc. for further instructions on how to proceed with the recall and to obtain updated documentation or guidance regarding the sterilization of the affected components.
The recalled product
- Product
- PINPOINT Endoscopic Fluorescence Imaging System
- Manufacturer
- Novadaq Technologies Inc.
- Affected units
- 110
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Rev. J
- Rev. K
- Rev. L and Rev. M Model Number : PC9000
Distribution
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