PINPOINT Endoscopic Fluorescence Imaging System
FDA Recall Z-1032-2016 · Posted None
Recalling FirmNovadaq Technologies Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2016-01-29
Date Terminated2016-11-03
Product Quantity110 units
Reason for Recall
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.
Firm Action
Novadaq sent an Urgent Device Correction letter dated
February 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Recipients of this notice have received shipments that include the inaccurate Operator's Manual.
Please follow these instructions:
1. Discard any old PINPOINT Operator's Manuals Rev J through M.
2. Accept and review the new PINPOINT Operator's Manual (Rev N).
3. Complete and sign the enclosed "Acknowledgement of Receipt" form, scan it and email to PI [email protected]. Any questions or concerns may also be sent to this address. For further questions, please call 1-(844) 668-2327, ( Select Option # 1)
Root Cause
Process design
Distribution Pattern
Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.