Recall Z-2767-2016 ยท IZI System, X-Ray, Angiographic
NOVADAQ TECHNOLOGIES INC.
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coron
| Date | Aug 18, 2016 |
| Status | Terminated |
| Reason | Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing. |
| Root cause | Packaging |
| Action | The firm, Novadaq, sent an "URGENT DEVICE CORRECTION: SK6000 PAQ Drape Pouch" letter dated 8/18/2016 to affected consignees. The Firm instructed consignee to cease distribution of affected product; accept the shipping-validated replacement PAQ; complete and sign the enclosed "Acknowledgment of Receipt" form, scan it and email to quality@novadaq.com. If you have any questions, contact Director of Regulatory Affairs at 1-905-629-3822 ext 205 or email: jpendlebury@novadaq.com. . |
| Quantity | 20 units |
| Distribution | US Distribution in states of: FL, MI, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042961 | SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 Novadaq Technologies, Inc., Jan 19, 2005 |
| K060867 | SPY INTRAOPERATIVE IMAGING SYSTEM Novadaq Technologies, Inc., May 3, 2006 |
| K063345 | SPY IMAGING SYSTEM Novadaq Technologies, Inc., Jan 12, 2007 |
| K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 Novadaq Technologies, Inc., May 10, 2007 |
| K071619 | SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc., Nov 9, 2007 |
| K072222 | SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc., Sep 7, 2007 |