CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report

Pinpoint Endoscopic Fluorescence Imaging System recalled

Novadaq Technologies is recalling Pinpoint Endoscopic Fluorescence Imaging System, distributed nationwide in the US. The recall was initiated on 29 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000

Quantity recalled110 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1032-2016
FDA event ID: 73225
Recalling firm: Novadaq Technologies, Burnaby, N/A
Classification: Class II
Status: Terminated
Recall initiated: 29 Jan 2016
FDA classified: 2 Mar 2016
Reported: 9 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

29 Jan 2016	Recall initiated by company
2 Mar 2016	Classified by FDA	+33 days
9 Mar 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

PINPOINT Endoscopic Fluorescence Imaging System

Where it was distributed

Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000

Where was it sold?

Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Novadaq Technologies

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Reported	Class	Recall	Company	Reason	Where
4 Oct 2017Device	CLASS II	Novadaq Spy-phi Drape, 7" x 104" recalled by Novadaq Technologies	Novadaq Technologies	Sterility	Nationwide
4 Oct 2017Device	CLASS II	Novadaq Spy-phi Paq Intended for use recalled by Novadaq Technologies	Novadaq Technologies	Sterility	Nationwide
4 Oct 2017Device	CLASS II	Novadaq Spy-phi Drape, 7" x 104" recalled by Novadaq Technologies	Novadaq Technologies	Sterility	Nationwide
14 Sep 2016Device	CLASS II	Sterile Drape, SK6000 PAQ drape pouch (for use recalled	Novadaq Technologies	Other	FL, MI, VA
3 Dec 2014Device	CLASS III	Non-sterile drape recalled by Novadaq Technologies	Novadaq Technologies	Labeling Errors	Nationwide

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