CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report

Kowa VK-2s recalled by Kowa Optimed

Kowa Optimed is recalling Kowa VK-2s, distributed nationwide in the US. The recall was initiated on 3 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 32168900007, 32168900008, 32168900009, 32168900010, 32168900011, 32168900019, 32168900020, 32168900021, 32168900022, 32168900025, 32168900035, 32168900036, 32168900037, 32168900044, 32168900045, 32169000052, 32169000144, 32169000145, 32169000152, 32169000153, 32169000166, 32169000167, 32169000168

Quantity recalledN/A

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-0636-2021
FDA event ID: 86737
Recalling firm: Kowa Optimed, Torrance, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2020
FDA classified: 17 Dec 2020
Reported: 23 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

3 Nov 2020	Recall initiated by company
17 Dec 2020	Classified by FDA	+44 days
23 Dec 2020	Published in enforcement report	+6 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 software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.

Where it was distributed

US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.

Nationwide Connecticut Idaho Illinois Massachusetts Michigan New York Texas Washington

Questions about this recall

Is Kowa VK-2s recalled?

Yes. Kowa Optimed recalled Kowa VK-2s on 3 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0636-2021.

Why was it recalled?

Which lots are affected?

Serial Numbers: 32168900007, 32168900008, 32168900009, 32168900010, 32168900011, 32168900019, 32168900020, 32168900021, 32168900022, 32168900025, 32168900035, 32168900036, 32168900037, 32168900044, 32168900045, 32169000052, 32169000144, 32169000145, 32169000152, 32169000153, 32169000166, 32169000167, 32169000168

Where was it sold?

US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.

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

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide