Devices

Device Recall NOVADAQ SPYPHI PAQ

Model / Serial
PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
Product Description
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.
Manufacturer
NOVADAQ TECHNOLOGIES INC.
1 Event
- Recall of Device Recall NOVADAQ SPYPHI PAQ

Manufacturer

NOVADAQ TECHNOLOGIES INC.

Manufacturer Address
NOVADAQ TECHNOLOGIES INC., 8329 Eastlake Dr Unit 101, Burnaby Canada
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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