CLASS II ONGOING Device recall · Reported 12 Aug 2015 · FDA Enforcement Report

Analytical X-ray System recalled by Olympus Scientific Solutions

Olympus Scientific Solutions Americas is recalling Analytical X-ray System, distributed nationwide in the US. The recall was initiated on 9 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDelta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.

Quantity recalled1047

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-1991-2015
FDA event ID: 71649
Recalling firm: Olympus Scientific Solutions Americas, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jun 2015
FDA classified: 31 Jul 2015
Reported: 12 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Imaging Equipment

Timeline

9 Jun 2015	Recall initiated by company
31 Jul 2015	Classified by FDA	+52 days
12 Aug 2015	Published in enforcement report	+12 days

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

Reason for recall

Higher than published scatter around the probe head when testing some samples. At the point the customer would interact directly with the instrument (Trigger position), most readings were lower. However, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum).

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.

Where was it sold?

Nationwide Distribution.

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.

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
8 Feb 2017Device	CLASS II	(Ossa) Vanta¿ Xrf Analyzer recalled by Olympus Scientific Solutions	Olympus Scientific Solutions Americas	Other	22 states
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

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