FDA Medical Device Recalls (openFDA)
Novadaq Technologies Inc.: PINPOINT Endoscopic Fluorescence Imaging System
- Recall number
- Z-1032-2016
- Recalling firm
- Novadaq Technologies Inc.
- Product
- PINPOINT Endoscopic Fluorescence Imaging System
- Status
- Terminated
- Initiated
- 2016-01-29
- Posted
- not on file
- Terminated
- 2016-11-03
- Reason
- 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.
- Root cause
- Process design
- Action
- Novadaq sent an Urgent Device Correction letter dated February 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients of this notice have received shipments that include the inaccurate Operator's Manual. Please follow these instructions: 1. Discard any old PINPOINT Operator's Manuals Rev J through M. 2. Accept and review the new PINPOINT Operator's Manual (Rev N). 3. Complete and sign the enclosed "Acknowledgement of Receipt" form, scan it and email to PI NPOINT@novadaq.com. Any questions or concerns may also be sent to this address. For further questions, please call 1-(844) 668-2327, ( Select Option # 1)
- Quantity
- 110 units
- Distribution
- Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
- Lot, serial or model codes
- Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000
- 510(k) numbers
- ["K091515"]
- PMA numbers
- not on file
- Product code
- GCJ
- 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