Recall Z-1032-2016 ยท GCJ Laparoscope, General & Plastic Surgery
Novadaq Technologies Inc.
PINPOINT Endoscopic Fluorescence Imaging System
| Date | Jan 29, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| 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 NPOINT@novadaq.com. Any questions or concer |
| Quantity | 110 units |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091515 | SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM Novadaq Technologies, Inc., Jul 9, 2009 |