Z-1032-2016Class II

PINPOINT Endoscopic Fluorescence Imaging System

Name: Z-1032-2016 PINPOINT Endoscopic Fluorescence Imaging System
Creator: Novadaq Technologies Inc.
Published: 2016-01-29
License: https://open.fda.gov/license/

Novadaq Technologies ULC / initiated 2016-01-29 / Terminated / root cause: manufacturing process

FDA source

Novadaq Technologies Inc. began a recall of PINPOINT Endoscopic Fluorescence Imaging System on 2016-01-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1032-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Posted: 2016-03-02
Terminated: 2016-11-03
Recalling firm: Novadaq Technologies ULC
Product: PINPOINT Endoscopic Fluorescence Imaging System
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. Any questions or concerns may also be sent to this address. For further questions, please call 1-(844) 668-2327, ( Select Option # 1)
Quantity in commerce: 110 units
Distribution: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
Product codes and lots: Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1032-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1032-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-02

Product code GCJ

K091515Class IISpy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. / cleared 2009-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)