🔍 RecallPedia

NOVADAQ TECHNOLOGIES

4 recalls •
🏥 Medical Devices
• Categories: Other Medical Devices, Diagnostic Equipment

NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

Class I - Dangerous

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

Jun 27, 2017 Other Medical Devices Nationwide View Details →

NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

Class I - Dangerous

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

Jun 27, 2017 Other Medical Devices Nationwide View Details →

NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

Class I - Dangerous

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

Jun 27, 2017 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

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.

Aug 18, 2016 Diagnostic Equipment View Details →

PINPOINT Endoscopic Fluorescence Imaging System

Class I - Dangerous

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.

Jan 29, 2016 Diagnostic Equipment Nationwide View Details →

Non-sterile drape

Class I - Dangerous

Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

Nov 4, 2014 Other Medical Devices Nationwide View Details →