FDA Medical Device Recalls (openFDA)
NOVADAQ TECHNOLOGIES INC.: 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.
- Recall number
- Z-3235-2017
- Recalling firm
- NOVADAQ TECHNOLOGIES INC.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-06-27
- Posted
- not on file
- Terminated
- 2017-12-11
- Reason
- The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm, Novadaq, issued an "URGENT DEVICE RECALL" letter dated 6/15/2017 via delivery by firm sales representatives or courier service (such as FedEx or UPS) on 6/27/2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to return unused product to Novadaq representative and complete and return the Acknowledgement of Receipt form by email to Novadaq Quality Department at quality@novadaq.com within 24 hours of receipt. Any questions or concerns may also be sent the listed email address. If you have any questions, please do not hesitate to contact the Director of Regulatory Affairs at 1.905.629.3822 ext 205 or email: jpendlebury@novadaq.com.
- Quantity
- 16/6-drape kits
- Distribution
- Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
- Lot, serial or model codes
- PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.
- 510(k) numbers
- ["K041501"]
- PMA numbers
- not on file
- Product code
- MMP
- Firm FEI
- 3012345110
- Firm city
- Burnaby
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28