CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report

(Ossa) Vanta¿ Xrf Analyzer recalled by Olympus Scientific Solutions

Olympus Scientific Solutions Americas is recalling Olympus Scientific Solutions Americas Corporation (Ossa) Vanta¿ Xrf Analyzer, distributed in 22 states. The recall was initiated on 7 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesaffects all units.

Quantity recalledUS 74

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-1036-2017
FDA event ID: 76208
Recalling firm: Olympus Scientific Solutions Americas, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 7 Jan 2017
FDA classified: 1 Feb 2017
Reported: 8 Feb 2017
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

7 Jan 2017	Recall initiated by company
1 Feb 2017	Classified by FDA	+25 days
8 Feb 2017	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 was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.

Product as listed by the FDA

Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems

Where it was distributed

US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.

Arizona California Colorado Georgia Illinois Indiana Kansas Louisiana Massachusetts Maryland Minnesota North Carolina New Hampshire New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Texas

Questions about this recall

Is (Ossa) Vanta¿ Xrf Analyzer recalled?

Yes. Olympus Scientific Solutions Americas recalled (Ossa) Vanta¿ Xrf Analyzer on 7 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1036-2017.

Why was it recalled?

Which lots are affected?

affects all units.

Where was it sold?

US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.

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.

Reported	Class	Recall	Company	Reason	Where
9 Aug 2017Device	CLASS II	Olympus Scientific Solutions Americas Corporation (Ossa) Model recalled	Olympus Scientific Solutions Americas	Device Malfunction	Nationwide
14 Dec 2016Device	CLASS II	Olympus Scientific Solutions Americas Corporation (Ossa) Model recalled	Olympus Scientific Solutions Americas	Other	16 states
10 Aug 2016Device	CLASS II	Olympus Scientific Solutions Americas Corporation (Ossa) Model recalled	Olympus Scientific Solutions Americas	Device Malfunction	Nationwide
2 Mar 2016Device	CLASS II	( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system recalled	Olympus Scientific Solutions Americas	Device Malfunction	Nationwide
12 Aug 2015Device	CLASS II	Analytical X-ray System recalled by Olympus Scientific Solutions	Olympus Scientific Solutions Americas	Foreign Material	Nationwide

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