Recall Z-2767-2016— NOVADAQ TECHNOLOGIES INC.
Class II · Terminated
Class II FDA medical device recall by NOVADAQ TECHNOLOGIES INC., initiated 2016-08-18, terminated 2016-12-09. It names 6 FDA 510(k) clearances: K071619, K072222, K071037 and 3 more. Product: 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 coronary artery bypass (BABG) surgery.. 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..
- Recalling firm
- NOVADAQ TECHNOLOGIES INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-18
- Terminated
- 2016-12-09
- Firm location
- Burnaby, Canada
510(k) clearances named in this recall
6 on FDA's record- K071619 — SPY FLUORESCENT IMAGING SYSTEM
- K072222 — SPY FLUORESCENT IMAGING SYSTEM
- K071037 — SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
- K063345 — SPY IMAGING SYSTEM
- K060867 — SPY INTRAOPERATIVE IMAGING SYSTEM
- K042961 — SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 coronary artery bypass (BABG) surgery.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.